Panels › Obstetrics/Gynecology › Product code HIC · Class 2
Speculum, Vaginal, Nonmetal, Fiberoptic
Regulation 884.4530
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HIC
| Company | 510(k)s | Recalls |
|---|---|---|
| Galenica Enterprises, Inc. | 1 | 0 |
| Sims Surgical, Inc. | 1 | 0 |
| Tri-State Hospital Supply Corp. | 1 | 0 |
| Trylon Corp. | 1 | 0 |
| Trylon Associates, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 1996 | K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY Trylon Corp. | HIC |
| Sep 8, 1994 | K923656 | LIGHTING SOURCE SYSTEM Galenica Enterprises, Inc., CA | HIC |
| Jul 3, 1990 | K902516 | NEW LENGTH SUGITA APPLIERS Sims Surgical, Inc. | HIC |
| Mar 16, 1990 | K897100 | CENTURION VAGINAL SPECULUM Tri-State Hospital Supply Corp. | HIC |
| Dec 27, 1985 | K853257 | SPECULITE DISPOSABLE VAGINAL LIGHT Trylon Associates, Ltd. | HIC |
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