Panels › Gastroenterology, Urology › Product code FFP · Class 1
Dilator, Rectal
Regulation 876.5450
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 FFP
| Company | 510(k)s | Recalls |
|---|---|---|
| Cleveland Medical Supply & Services | 1 | 0 |
| Inamed Development Co. | 1 | 0 |
| Mk Conquest Intl., Inc. | 1 | 0 |
| Primrose Medical, Inc. | 1 | 0 |
| Telemed Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 6, 1997 | K964634 | ANOKRYO Mk Conquest Intl., Inc. | FFP |
| Jun 21, 1990 | K901426 | COLONIC BALLOON DILATOR Telemed Systems, Inc. | FFP |
| Jan 18, 1990 | K894618 | INAMED RHEMO-D (TM) DILATOR Inamed Development Co. | FFP |
| Sep 29, 1989 | K884713 | COLONIC BALLOON DIALATORS Primrose Medical, Inc. | FFP |
| May 27, 1983 | K830354 | COLORECTAL DILATOR Cleveland Medical Supply & Services | FFP |
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