The following data is part of a premarket notification filed by Alphamedix, Inc. with the FDA for Versaphage.
| Device ID | K851272 |
| 510k Number | K851272 |
| Device Name: | VERSAPHAGE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ALPHAMEDIX, INC. 10907 NORTHRIDGE SQUARE Cupertino, CA 95014 |
| Contact | Carl R Jordan |
| Correspondent | Carl R Jordan ALPHAMEDIX, INC. 10907 NORTHRIDGE SQUARE Cupertino, CA 95014 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-07-05 |