The following data is part of a premarket notification filed by Wiest Usa, Inc. with the FDA for Cavomat.
| Device ID | K911388 |
| 510k Number | K911388 |
| Device Name: | CAVOMAT |
| Classification | Device, Erectile Dysfunction |
| Applicant | WIEST USA, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin WIEST USA, INC. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | LST |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-29 |
| Decision Date | 1991-12-04 |