Panels › General Hospital › Product code FME · Class 1
Gown, Examination
Regulation 880.6265
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FME
| Company | 510(k)s | Recalls |
|---|---|---|
| American Hospital Supply Corp. | 1 | 0 |
| Encompass Group LLC | 0 | 1 |
| General Medical Co. | 1 | 0 |
| Graham Manufacturing Co. | 1 | 0 |
| Kimberly-Clark Corp. | 1 | 0 |
| Precept, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 1988 | K880385 | KIMBERLY-CLARK PROFESSIONAL JACKET Kimberly-Clark Corp. | FME |
| Jul 28, 1981 | K811915 | MONITOR/VITAL SIGNS TRAY American Hospital Supply Corp. | FME |
| May 6, 1977 | K770476 | EXAM GOWN General Medical Co. | FME |
| Dec 30, 1976 | K760954 | CROWNTEX EXAM. CAPE & GOWN Graham Manufacturing Co. | FME |
| Oct 20, 1976 | K760360 | SHIRT, MITTEN CUFF INFANT Precept, Inc. | FME |
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