FDA 510(k) Applications for Medical Device:
Container, Sharps
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K071517 | A.B.M. ITALIA S.P.A |
VIA LNG. G. TALIERCIO, 1 | RONCADELLE DI ORMELLE | 31024 | |
| K060037 | ASP PLASTICS PTY LTD. |
2700 LA PAZ ROAD, SUITE 314 | MISSION VIEJO | CA | 92691 |
| K112774 | Becton, Dickinson and Company |
1 BECTON DRIVE MC 372 | FRANKLIN LAKES | NJ | 07417 |
| K140285 | BELLEGROVE MEDICAL SUPPLY, INC. |
8349 154TH AVE NE | REDMOND | WA | 98052 |
| K960525 | BEMIS MFG. CO. |
300 MILL ST. | SHEBOYGAN FALLS | WI | 53085 |
| K964858 | BEMIS MFG. CO. |
300 MILL ST. | SHEBOYGAN FALLS | WI | 53085 |
| K063666 | BIODEX MEDICAL SYSTEMS, INC. |
20 RAMSAY RD. | SHIRLEY | NY | 11967 |
| K182235 | Bluestone Medical, Inc. |
(DBA OnSite Waste Technologies, Inc.) | East Hampton | NY | 11937 |
| K131708 | BRADFORD WRIGHT COMPANIES, INC |
4092 ORCHARD WAY | LAKE OSWEGO | OR | 97035-1871 |
| K101567 | CIXI LEINUO PLASTIC CO. LTD |
NO. 56 LUOMING SOUTH ROAD | NINGBO | 315316 | |
| K091736 | DANIELS CORPORATION PTY, INC. |
2133-126 UPTON DRIVE | VIRGINIA BEACH | VA | 23454 |
| K132792 | DANIELS SHARPSMART, INC. |
12264 EL CAMINO REAL, STE #400 | SAN DIEGO | CA | 92130 |
| K955514 | DURA-VAC PRODUCTS |
4464 MCGRATH ST., #114 | VENTURA | CA | 93003 |
| K081821 | GLOBAL PATHOGEN SOLUTIONS INC. |
9515 N.E. 312TH AVE. | CAMAS | WA | 98607 |
| K964387 | GRAPHIC CONTROLS CORP. |
9530 DESOTO AVE. | CHATSWORTH | CA | 91311-5084 |
| K132476 | GRP & ASSOCIATES |
816 CONGRESS, SUITE 1400 | AUSTIN | TX | 78701 |
| K983367 | HANDREN ASSOC. |
5818 PR. CAROLINE PL. | LEESBURG | FL | 34748 |
| K172719 | HealthBeacon Ltd |
Unit 20, Naas Road Business Park, Muirfield Drive | Dublin | Dublin 12 | |
| K091690 | HEATHROW SCIENTIFIC, LLC |
620 LAKEVIEW PKWY | VERNON HILLS | IL | 60061 |
| K083511 | INDUSTRIAL WATER SOLUTIONS, INC |
2692 WILLOWLAWN STREET | ROANOKE | VA | 24018 |
| K133031 | INDUSTRIAL WATER SOLUTIONS, INC. |
2692 WILLOWLAWN STREET, S.W. | Roanoke | VA | 24018 |
| K203305 | International Marketing Specialists Inc. |
1278 HWY 461 | Somerset | KY | 42503 |
| K190240 | International Marketing Specialists Inc. |
1278 HWY 461 | Somerset | KY | 42503 |
| K170513 | Mauzer USA LLC |
2 Tower Center Drive, 20th floor | East Brunswick | NJ | 08816 |
| K123807 | MEDICAL ENGINEERING DEVELOPMENT SOLUTIONS, INC. |
11060 IRMA DRIVE | NORTHGLENN | CO | 80233 |
| K132767 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K143693 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDLELEIN | IL | 60060 |
| K070577 | MEDPORT, INC. |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K150333 | MedSource International, LLC |
401 Norex Drive | Chaska | MN | 55318 |
| K222906 | Ningbo Maxcon Medical Technology Co., Ltd. |
No.228 Dongxin Road, Dongqiao Town | Ningbo | 315000 | |
| K180984 | Ningbo Maxcon Medical Technology Co., Ltd. |
No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town | Ningbo | 315157 | |
| K222905 | Ningbo Maxcon Medical Technology Co., Ltd. |
No.228 Dongxin Road, Dongqiao Town | Ningbo | 315000 | |
| K180983 | Ningbo Maxcon Medical Technology Co., Ltd. |
No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town | Ningbo | 315157 | |
| K211464 | Nitta M&T (Thailand) Co., Ltd. |
19/52 Unit G5, Phaholyothin Rd., Moo 10 Khlong Nueng | Khlong Luang | 12120 | |
| K110262 | NOBLE MARKETING |
11460 N. MERIDIAN ST. | CARMEL | IN | 46032 |
| K152340 | North American Rescue, LLC |
35 Tedwall Court | Greer | SC | 29650 |
| K141759 | OAK RIDGE PRODUCTS, LLC |
4612 Century Ct | McHenry | IL | 60050 |
| K130281 | OAK RIDGE PRODUCTS, LLC |
4612 Century Ct | McHenry | IL | 60050 |
| K161180 | OAK RIDGE PRODUCTS, LLC |
4612 Century Ct | McHenry | IL | 60050 |
| K211890 | Promisemed Hangzhou Meditech Co., Ltd. |
No. 1388 Cangxing Street, Cangqian Community,Yuhang District | Hangzhou City | 311121 | |
| K231484 | PureWay Compliance Inc. |
201 Santa Monica Blvd, Suite 400 | Santa Monica | CA | 90401 |
| K151249 | PUREWAY COMPLIANCE, INC |
201 SANTA MONICA BLVD. SUITE 400 | SANTA MONICA | CA | 90401 |
| K213274 | Qlicksmart Pty Ltd. |
Level 1, 148 Boundary Street, West End | Brisbane | 4101 | |
| K111085 | REHRIG PACIFIC COMPANY |
614 HUNTERS LANE | BRENTWOOD | TN | 37027 |
| K131087 | REHRIG PACIFIC COMPANY |
614 HUNTERS LANE | BRENTWOOD | TN | 37027 |
| K980490 | SAGE PRODUCTS, INC. |
815 TEK DR. | CRYSTAL LAKE | IL | 60014-8172 |
| K083129 | SHARPS COMPLIANCE, INC. |
9220 KIRBY DR., SUITE 500 | HOUSTON | TX | 77054 |
| K073577 | SHARPS COMPLIANCE, INC. |
614 HUNTERS LANE | BRENTWOOD | TN | 37027 |
| K153274 | Snyder Industries, Inc. |
6940 O Street Suite 100 | Lincoln | NE | 68510 |
| K072667 | SOLUTIONS, INC. |
3600 CHAMBERLAIN LANE | LOUISVILLE | KY | 40241 |
| K132007 | STERICYCLE, INC. |
755 N. MATHILDA AVE., | SUNNYVALE | CA | 94085 |
| K991612 | STERILOGIC WASTE SYSTEMS, INC. |
9948 KISTLER VALLEY RD., #102 | KEMPTON | PA | 19529-0084 |
| K020664 | STERILOGIC WASTE SYSTEMS, INC. |
6691 PICKARD DR. | SYRACUSE | NY | 13211 |
| K063722 | TECHEN SAFETY, INC. |
55 Northern Blvd | Great Neck | NY | 11021 |
| K001337 | THE DANIELS CORP. |
4329 GRAYDON RD. | SAN DIEGO | CA | 92130 |
| K982781 | THERMAL WASTE TECHNOLOGY, INC. |
19 STONY HILL RD. | BETHEL | CT | 06801 |
| K153363 | TRIUMVIRATE ENVIRONMENTAL, INC. |
200 INNER BELT ROAD | Somerville | MA | 02143 |
| K021983 | ULTI MED, INC. |
287 EAST SIXTH ST. | ST. PAUL | MN | 55101 |
| K081449 | ULTIMED, INC. |
5353 WAYZATA BLVD. | MINNEAPOLIS | MN | 55416-1334 |
| K090157 | WCM WASTE & COMPLIANCE MANAGEMENT, INC. |
1330 CONNECTICUT AVE., NW | WASHINGTON | DC | 20036 |
| K082042 | ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
BEICHENG INDUSTRIAL AREA | HUANGYAN, TAIZHOU, ZHEJIANG | 318020 | |
| K201523 | Zhejiang Gongdong Medical Technology Co., Ltd |
No.10, Beiyuan Avenue, Huangyan | Taizhou | 318020 |
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