The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Versa-vu.
| Device ID | K951898 |
| 510k Number | K951898 |
| Device Name: | VERSA-VU |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Contact | John Chapman |
| Correspondent | John Chapman COOPERSURGICAL, INC. 15 FOREST PKWY. Shelton, CT 06484 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937000115 | K951898 | 000 |
| 00888937000078 | K951898 | 000 |