The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Cc/brush.
| Device ID | K896065 |
| 510k Number | K896065 |
| Device Name: | WALLACH CC/BRUSH |
| Classification | Spatula, Cervical, Cytological |
| 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 | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-18 |
| Decision Date | 1990-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937013291 | K896065 | 000 |
| 20888937011320 | K896065 | 000 |
| 20888937011313 | K896065 | 000 |
| 20888937011306 | K896065 | 000 |
| 20888937011290 | K896065 | 000 |
| 50888937011284 | K896065 | 000 |
| 50888937011277 | K896065 | 000 |