The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Flexible Endometrial Sampler.
| Device ID | K902693 |
| 510k Number | K902693 |
| Device Name: | WALLACH FLEXIBLE ENDOMETRIAL SAMPLER |
| Classification | Aspirator, Endometrial |
| 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 | HFF |
| CFR Regulation Number | 884.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-19 |
| Decision Date | 1991-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937011266 | K902693 | 000 |
| 30888937011259 | K902693 | 000 |
| 00888937011241 | K902693 | 000 |