The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Convertible Colposcope.
| Device ID | K871682 |
| 510k Number | K871682 |
| Device Name: | WALLACH CONVERTIBLE COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Contact | Vincent Frazzetta |
| Correspondent | Vincent Frazzetta WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937014723 | K871682 | 000 |
| 00888937013719 | K871682 | 000 |