The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Zoom Colposcope.
| Device ID | K853389 |
| 510k Number | K853389 |
| Device Name: | WALLACH ZOOM COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | WALLACH SURGICAL DEVICES, INC. 273 LINWOOD AVE. Fairfield, CT 06430 |
| Contact | Ronald Rzasa |
| Correspondent | Ronald Rzasa WALLACH SURGICAL DEVICES, INC. 273 LINWOOD AVE. Fairfield, CT 06430 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-13 |
| Decision Date | 1985-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888937013740 | K853389 | 000 |
| 00888937013733 | K853389 | 000 |
| 00888937013726 | K853389 | 000 |
| 00888937013702 | K853389 | 000 |
| 00888937013696 | K853389 | 000 |
| 00888937013689 | K853389 | 000 |
| 00888937013672 | K853389 | 000 |
| 00888937013665 | K853389 | 000 |