FDA 510(k) Applications for Medical Device:
Speculum, Vaginal, Nonmetal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K040817 | ADVANCED UROLOGICAL DEVELOPMENTS |
485 DARTMOUTH AVENUE | SAN CARLOS | CA | 94070 |
| K130046 | CLEARSPEC LLC |
603 GRANT STREET | HERKIMER | NY | 13350 |
| K021676 | CYPRESS MEDICAL PRODUCTS, LTD. |
1202 SOUTH ROUTE 31 | MCHENRY | IL | 60050 |
| K072762 | DEPALT INC. |
5013 STONEWICK COURT | PLANO | TX | 75093 |
| K012535 | DOCTOR'S RESEARCH GROUP, INC. |
143 WOLCOTT RD. | WOLCOTT | CT | 06716 |
| K020726 | DUKAL CORP. |
3234 ELLA LN. | NEW PORT RICHE | FL | 34655 |
| K052314 | DYNAREX CORP. |
10 GLENSHAW ST. | ORANGEBURG | NY | 10962 |
| K013835 | DYNASCEND CONSULTING INT'L LLC. |
1144 CANTON ST., SUITE 103 | ROSWELL | GA | 30075 |
| K003540 | FEMINICA, INC. |
3216 MONSABRE | MONTREAL, QUEBEC | H1N 2L5 | |
| K052192 | FEMSPEC L.L.C. |
1530 HOLCOMB STREET | PORT TOWNSEND | WA | 98368 |
| K041757 | FEMSPEC L.L.C. |
220 HALLECK STREET, SUITE 120 | SAN FRANCISCO | CA | 94129-0450 |
| K974228 | GPS |
11 LOWELL RD. | PORT WASHINGTON | NY | 11050 |
| K052420 | GYNOVA, LLC |
698 MIDDLE TNPK E | MANCHESTER | CT | 06040 |
| K060129 | INNOVATIVE GYNECOLOGICAL SOLUTIONS LLC |
5 WENTWORTH DRIVE | HUDSON | NH | 03051 |
| K132668 | IOB MEDICAL INC |
504E DIAMOND AVE. | GAITHERSBURG | MD | 20877 |
| K021017 | ITL CORPORATION, PTY LTD. |
41-45 TENNANT ST. | FYSHWICK, CANBERRA ACT | 2609 | |
| K030761 | JIANGSU KAISHOU MEDICAL APPARATUS CO., LTD |
600 LIU ZHOU ROAD | SHANGHAI | 200233 | |
| K030693 | KENTRON HEALTH CARE, INC. |
3604 KELTON JACKSON ROAD | SPRINGFIELD | TN | 37172 |
| K110766 | KOLPLAST CI LTDA |
1468 Harwell Avenue | Crofton | MD | 21114 |
| K973853 | KOLPLAST COMERCIAL E INDUSTRIAL LTDA |
P.O BOX 4341 | CROFTON | MD | 21114 |
| K092870 | KUNSHAN DEYI PLASTIC CO., LTD. |
77325 JOYCE WAY | ECHO | OR | 97826 |
| K000414 | MARKETING PERSPECTIVES |
6565 146TH AVE. | HOLLAND | MI | 49423 |
| K022948 | MEDICAL ACTION INDUSTRIES, INC. |
2 SUMMIRT DR. | ARDEN | NC | 28704 |
| K061339 | MEDICAL PRODUCTS DIV. |
2410 EXECUTIVE DRIVE | INDIANAPOLIS | IN | 46241 |
| K072942 | MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE | MUNDELEIN | IL | 60060 |
| K984211 | MEDSCAND AB |
P.O. BOX 20047 | MALMO | 520074 | |
| K963377 | NORTH EOS INDUSTRIES, INC. |
54, LANE 1, BEEN ST. | TAICHUNG HSIEN | ||
| K091937 | OBP CORPORATION |
360 MERRIMACK STREET | LAWRENCE | MA | 01843 |
| K042950 | PANATREX, INC. |
1648 SIERRA MADRE CIR. | PLACENTIA | CA | 92870-6626 |
| K991963 | PATTON MEDICAL CORP. |
1000 WESTBANK DR. | AUSTIN | TX | 78746 |
| K971979 | PLAYTEX PRODUCTS, INC. |
215 COLLEGE RD. | PARAMUS | NJ | 07652 |
| K000444 | PRISM ENTERPRISES, INC. |
10 AUBREY COURT | SAN ANTONIO | TX | 78216 |
| K133857 | PROA MEDICAL, INC. |
2512 Artesia Blvd Ste 305C | Redondo Beach | CA | 90278 |
| K991827 | RI MOS. S.R.L. |
100 MAIN ST. | CONCORD | MA | 01742 |
| K013817 | SOL WEISS MD INC |
7012 RESEDA BLVD. | RESEDA | CA | 91335 |
| K020959 | SOL WEISS MD INC |
7012 RESEDA BLVD. | RESEDA | CA | 91335 |
| K012859 | SOL WEISS MD INC |
7012 RESEDA BLVD. | RESEDA | CA | 91335 |
| K002912 | STERINC |
3520 W. WARNER AVE. | SANTA ANTA | CA | 92704 |
| K021849 | TAGG INDUSTRIES |
23210 DEL LAGO | LAGUNA HILLS | CA | 92653 |
| K983716 | VITALCARE GROUP, INC. |
15800 N.W. 13TH AVE. | MIAMI | FL | 33169 |
| K992736 | WALLACH SURGICAL DEVICES, INC. |
235 EDISON RD. | ORANGE | CT | 06477 |
| K070964 | WELCH ALLYN, INC. |
4341 STATE STREET ROAD | SKANEATELES FALLS | NY | 13153-0220 |
| K120743 | WELCH ALLYN, INC. |
4341 STATE ST. RD. | SKANEATELES FALLS | NY | 13153-0220 |
| K050887 | ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY |
BEICHENG INDUSTRIAL AREA | HUANGYAN | 318020 | |
| K052912 | ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. |
XUANMEN INDUSTRIAL ZONE, LUPU | ZHEJIANG PROVINCE, P.R. | 317608 | |
| K925501 | ZINNANTI SURGICAL INSTRUMENTS, INC. |
21540-B PRAIRIE ST. | CHATSWORTH | CA | 91311 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
