FDA 510(k) Applications for Medical Device:
Device, External Penile Rigidity
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971576 | AMERICAN MEDTECH |
1900 K STREET, N.W. | WASHINGTON, D.C. | DC | 20006 |
| K974196 | BARRY J. KAPLAN, INC. |
1286 UNIVERSITY AVE, SUITE 221 | SAN DIEGO | CA | 92103 |
| K001859 | BASIC SOLUTIONS, LLC. |
2425 W. OLYMPIC BLVD. | SANTA MONICA | CA | 90404 |
| K983438 | DOREA, INC. |
19 4TH AVENUE, S.E. | CAIRO | GA | 31728 |
| K974470 | ENCORE, INC. |
1900 K ST. , N.W. | WASHINGTON | DC | 20005 |
| K020082 | ENDOCARE, INC. |
6585 CITY WEST PKWY. | EDEN PRAIRIE | MN | 55344 |
| K972353 | ERCONS, INC. |
66 OVERLOOK TERRACE, SUITE 2E | NEW YORK | NY | 10040 |
| K981343 | ERCONS, INC. |
66 OVERLOOK TERRACE, SUITE 2E | NEW YORK | NY | 10040 |
| K990008 | ERCONS, INC. |
66 OVERLOOK TERRACE, SUITE 2E | NEW YORK | NY | 10040 |
| K972537 | ERCONS, INC. |
66 OVERLOOK TERRACE, SUITE 2E | NEW YORK | NY | 10040 |
| K981357 | ERCONS, INC. |
66 OVERLOOK TERRACE, SUITE 2E | NEW YORK | NY | 10040 |
| K990006 | ERCONS, INC. |
66 OVERLOOK TERRACE, SUITE 2E | NEW YORK | NY | 10040 |
| K993343 | ERECXEL ENTERPRISES |
3249 SAN FEMANDO RD. | LOS ANGELES | CA | 90065 |
| K974173 | IMAGYN MEDICAL TECHNOLOGIES, INC. |
5 CIVIC PLAZA, SUITE 100 | NEWPORT BEACH | CA | 92660 |
| K980291 | IMAGYN MEDICAL TECHNOLOGIES, INC. |
27651 LA PAZ RD. | LAGUNA NIGUEL | CA | 92677-3917 |
| K000730 | IMPOAID, INC. |
P.O. BOX 560 | STILLWATER | MN | 55082 |
| K955856 | LABORIE MEDICAL TECHNOLOGIES, LTD. |
6415 NORTHWEST DR. | MISSISSAUGA ONT. CANADA | L4V1X1 | |
| K971257 | MCKENNA & CUNEO |
1900 K STREET, N.W. | WASHINGTON | DC | 20006-1108 |
| K980948 | MISSION PHARMACAL COMP |
24 CARPENTER RD. | CHESTER | NY | 10918 |
| K013053 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K013113 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K013051 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K030119 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K993908 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K993906 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K030913 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K993909 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K041573 | NANMA MFG CO., LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K971443 | OWEN MUMFORD USA, INC. |
849 PICKENS INDUSTRIAL DR. | MARIETTA | GA | 30062 |
| K982275 | Owen Mumford USA, Inc. |
849 PICKENS INDUSTRIAL DR. | MARIETTA | GA | 30062 |
| K974082 | PERFORMANCE PLUS, INC. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K012670 | POS-T-VAC, INC. |
1701 NORTH 14TH AVE. | DODGE CITY | KS | 67801 |
| K012672 | POS-T-VAC, INC. |
1701 NORTH 14TH AVE. | DODGE CITY | KS | 67801 |
| K983245 | POS-T-VAC, INC. |
1701 NORTH 14TH AVE. | DODGE CITY | KS | 67801 |
| K983246 | POS-T-VAC, INC. |
1701 NORTH 14TH AVE. | DODGE CITY | KS | 67801 |
| K981011 | POS-T-VAC, INC. |
1455 PENNSYLVANIA AVE. N.W. | WASHINGTON | DC | 20004 |
| K960342 | POS-T-VAC, INC. |
2550 M STREET, N.W. | WASHINGTON | DC | 20037 |
| K960828 | POS-T-VAC, INC. |
2550 M STREET, N.W. | WASHINGTON | DC | 20037 |
| K981180 | POS-T-VAC, INC. |
1455 PENNSYLVANIA AVE. N.W. | WASHINGTON | DC | 20004 |
| K020258 | POS-T-VAC, INC. |
1701 NORTH 14TH AVE. | DODGE CITY | KS | 67801 |
| K020154 | POS-T-VAC, INC. |
1701 NORTH 14TH AVE. | DODGE CITY | KS | 67801 |
| K000124 | PROSURG, INC. |
2193 TRADE ZONE BLVD. | SAN JOSE | CA | 95131 |
| K981506 | REPRO-MED SYSTEMS, INC. |
24 CARPENTER RD. | CHESTER | NY | 10918 |
| K993142 | SOMA BLUE, INC. |
P.O. BOX 1447 | AUGUSTA | GA | 30903 |
| K993143 | SOMA BLUE, INC. |
P.O. BOX 1447 | AUGUSTA | GA | 30903 |
| K012620 | V.T.S.,INC. |
701 S. MAIN | NEWKIRK | OK | 74647 |
| K992442 | V.T.S.,INC. |
701 S. MAIN | NEWKIRK | OK | 74647 |
| K012619 | V.T.S.,INC. |
701 S. MAIN | NEWKIRK | OK | 74647 |
| K020969 | VACURECT MANUFACTURING (PTY) LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K032776 | VACURECT MANUFACTURING (PTY) LTD. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K974215 | VETCO, INC. |
3700 5TH AVE. SOUTH | BIRMINGHAM | AL | 35222 |
| K962915 | VIVUS, INC. |
545 MIDDLEFIELD RD., SUITE 200 | MENLO PARK | CA | 94025 |
| K003115 | VIVUS, INC. |
1172 CASTRO ST. | MOUNTAIN VIEW | CA | 94040 |
| K012662 | VTS, INC. |
701 S. MAIN ST. | NEWKIRK | OK | 74647 |
| K012639 | VTS, INC. |
701 S. MAIN ST. | NEWKIRK | OK | 74647 |
| K980567 | WALLING MEDICAL EQUIPMENT CO. |
3000 CANDIDE LN. | MCKINNEY | TX | 75070 |
| K971768 | WALLING MEDICAL EQUIPMENT CO. |
3000 CANDIDE LN. | MCKINNEY | TX | 75070 |
| K980752 | WALLING MEDICAL EQUIPMENT CO. |
3000 CANDIDE LN. | MCKINNEY | TX | 75070 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
