FDA 510(k) Applications for Medical Device:
Suture, Surgical, Absorbable, Polydioxanone
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K031216 | AESCULAP |
3773 CORPORATE PKWY. | CENTER VALLEY | PA | 18034 |
| K113744 | ANGIOTECH |
100 DENNIS DRIVE | READING | PA | 19606 |
| K120827 | ANGIOTECH |
100 DENNIS DRIVE | READING | PA | 19606 |
| K022666 | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
1591 S. MOORLAND RD. | NEW BERLIN | WI | 53151 |
| K150553 | ASSUT EUROPE |
ZONA INDUSTRIALE | MAGLIANO DEI MARSI | 1-67062 | |
| K120284 | COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH | MINNEAPOLIS | MN | 55411 |
| K013274 | CP MEDICAL |
836 N.E. 24TH AVE. | PORTLAND | OR | 97232 |
| K030786 | CP MEDICAL |
836 N.E. 24TH AVE. | PORTLAND | OR | 97232 |
| K082097 | DEMETECH CORP. |
8935 NW 27TH STREET | MIAMI | FL | 33172 |
| K191361 | DemeTECH Corporation |
14175 NW 60th Ave | Miami Lakes | FL | 33014 |
| K181582 | Demetech Corporation |
14175 NW 60th Ave | Miami Lakes | FL | 33014 |
| K043298 | Depuy Mitek |
249 VANDERBILT DR. | NORWOOD | MA | 02062 |
| K080918 | Depuy Mitek |
325 Paramount Drive | Raynham | MA | 02767 |
| K040004 | Depuy Mitek |
249 VANDERBILT DR. | NORWOOD | MA | 02062 |
| K123668 | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
325 Paramount Drive | Raynham | MA | 02767 |
| K160761 | DONGWON MEDICAL CO., LTD. |
201-HO, 35, SAAM-RO 340BEON-GIL | Gwangju | 62328 | |
| K212380 | Ethicon, Inc. |
1000 Route 202 | Raritan | NJ | 08869 |
| K061037 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876 |
| K113004 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K192144 | Ethicon, Inc. |
Route 22 West, P.O. Box 151 | Somerville | NJ | 08876-0151 |
| K150670 | ETHICON, INC. |
ROUTE 22 WEST, PO BOX 151 | SOMERVILLE | NJ | 08876 |
| K141776 | ETHICON, INC. |
ROUTE 22 WEST | SOMERVILLE | NJ | 08876-0151 |
| K182873 | Ethicon, Inc. |
Route 22 West, P.O. Box 151 | Somerville | NJ | 08876 |
| K172602 | Feeltech Co., Ltd. |
3,4 Floor Standard Factory 2-dong, 15 Jayumuyeok 2-gil | Gunsan-si | 573-540 | |
| K073614 | FOOSIN MEDICAL SUPPLIES INC. |
SUITE 8D, ZHONGXIN ZHONGSHAN | ZHONG SHAN, SHANGHAI | 20030 | |
| K201139 | Foosin Medical Supplies Inc., Ltd. |
No.20, Xingshan Road, Weihai Torch Hi-tech Science Park | Weihai | 264210 | |
| K030212 | GENZYME BIOSURGERY |
600 AIRPORT RD. | FALL RIVER | MA | 02720-4740 |
| K192423 | Hans Biomed Corporation |
7, Jeongui-ro 8-gil, Songpa-gu | Seoul | 05836 | |
| K220549 | Hans Biomed Corporation |
64, Yuseong-Daero 1628 Beon-Gil | Yuseong-Gu | 34054 | |
| K130191 | HANSBIOMED CORPORATION |
325 N PUENTE ST | BREA | CA | 92821 |
| K242571 | Hyundae Meditech Co., Ltd. |
80, Cheongjeong-ro, Jijeong-myeon | Wonju-si | 26347 | |
| K240389 | HyunDae MediTech Co., Ltd. |
80, Cheongjeong-ro, Jijeong-myeon, | Wonju-si | 26347 | |
| K041048 | INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K031443 | LSI SOLUTIONS |
7796 VICTOR-MENDON RD. | VICTOR | NY | 14564 |
| K232246 | M/s. Meril Endo Surgery Private Limited |
Third Floor, E1-E3, Meril Park Survey | Vapi | 396191 | |
| K190264 | MEDITIME Co., Ltd |
#605 Medical Device Complex, 200, Gieupdosi-ro, | Won Ju | 90010 | |
| K161737 | MYCO MEDICAL |
158 TOWERVIEW COURT | CARY | NC | 27513 |
| K162366 | OV WORLD CO., LTD |
(GASAN-DONG, FORMATEC BD)A-202,213 205-28, GASAN DIGITAL 1-R | SEOUL | ||
| K210871 | PDO MAX, Inc. |
4971 Bear Road | Liverpool | NY | 13088 |
| K190245 | PDO MAX, Inc. |
4971 Bear Road | Liverpool | NY | 13088 |
| K042075 | QUILL MEDICAL, INC. |
1600 STEWART AVE. | WESTBURY | NY | 11590 |
| K051609 | QUILL MEDICAL, INC. |
2505 MERIDIAN PKWY. | RESEARCH TRIANGLE PARK | NC | 27713 |
| K100461 | RIVERPOINT MEDICAL |
825 NE 25TH AVE. | PORTLAND | OR | 97232 |
| K053380 | SURGICAL SPECIALTIES CORP. |
100 DENNIS DR. | READING | PA | 19606 |
| K080680 | SURGICAL SPECIALTIES CORP. |
13921 PARK CENTER RD. | HERNDON | VA | 20171 |
| K080985 | SURGICAL SPECIALTIES CORP. |
13921 PARK CENTER RD. | HERNDON | VA | 20171 |
| K071989 | SURGICAL SPECIALTIES CORP. |
100 DENNIS DR. | READING | PA | 19606 |
| K063680 | SURGICAL SPECIALTIES CORP. |
100 DENNIS DR. | READING | PA | 19606 |
| K123877 | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
100 DENNIS DR. | READING | PA | 19606 |
| K133420 | SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
100 DENNIS DR. | READING | PA | 19606 |
| K132268 | SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH |
100 DENNIS DRIVE | READING | PA | 19606 |
| K081001 | SUTURES INDIA PVT., LTD. |
472 D, 13TH CROSS, 4TH PHASE | BANGALORE | 560058 | |
| K242835 | Suturion AB |
Scheeletorget 1 | Lund | 223 63 | |
| K250977 | Suturion AB |
Scheeletorget 1 | Lund | 223 63 | |
| K100780 | UNILENE S.A.C. |
5401 S. COTTONWOOD CT. | GREENWOOD VILLAGE | CO | 80121 |
| K042285 | UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY | RIYADH, CENTRAL PROVINCE | 11553 | |
| K160705 | Y. JACOBS MEDICAL, INC |
6F SANGKYUNG BLDG. 669 SEOLLEUNG-RO | SEOUL | 135-830 | |
| K143413 | Y. Jacobs Medical, Inc. |
6F Sangkyeong Bldg. 669 Seolleung-ro, Gangnam-gu | Seoul | 135830 |
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