Panels › General, Plastic Surgery › Product code FYE · Class 1
Dress, Surgical
Regulation 878.4040
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Barrier Concepts, Inc. | 1 | 0 |
| Clinitech, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 0 | 1 |
| Depuy-Raynham | 1 | 0 |
| Intermedics Orthopedics | 1 | 0 |
| Johnson & Johnson Medical, Inc. | 1 | 0 |
| Protect Corp. of Indiana, Inc. | 1 | 0 |
| Unicor Federal Dept. of Justice | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 1994 | K932731 | BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN Johnson & Johnson Medical, Inc. | FYE |
| Sep 19, 1991 | K912790 | SURGICAL GOWN Unicor Federal Dept. of Justice | FYE |
| May 15, 1991 | K910920 | PROTEKT GLOVES Intermedics Orthopedics | FYE |
| May 9, 1991 | K910941 | LIFELINER SURGICAL GLOVE Depuy-Raynham | FYE |
| Oct 13, 1989 | K895667 | STERILE SURGICAL GOWN Clinitech, Inc. | FYE |
| Sep 19, 1989 | K895235 | VARIOUS DISPOSABLE SURGICAL GARMENTS Protect Corp. of Indiana, Inc. | FYE |
| Aug 18, 1989 | K894760 | CLOTHINGUARD Barrier Concepts, Inc. | FYE |
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