The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Painblocker Wa5000.
| Device ID | K854334 |
| 510k Number | K854334 |
| Device Name: | PAINBLOCKER WA5000 |
| Classification | Device, Surgical, Cryogenic |
| 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 | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-28 |
| Decision Date | 1986-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818788022721 | K854334 | 000 |