The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Colpostar V-6.
| Device ID | K871683 | 
| 510k Number | K871683 | 
| Device Name: | COLPOSTAR V-6 | 
| 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 | 1987-08-05 |