The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Digital Imaging System.
| Device ID | K950630 |
| 510k Number | K950630 |
| Device Name: | WALLACH DIGITAL IMAGING SYSTEM |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Contact | Raymond A Wiley |
| Correspondent | Raymond A Wiley WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-11-22 |