The following data is part of a premarket notification filed by Diasonics, Inc. with the FDA for Access(tm), Software Release 4.11p.
| Device ID | K896637 |
| 510k Number | K896637 |
| Device Name: | ACCESS(TM), SOFTWARE RELEASE 4.11P |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | DIASONICS, INC. 280 UTAH AVE. S. San Francisco, CA 94080 |
| Contact | Ben Khosravi |
| Correspondent | Ben Khosravi DIASONICS, INC. 280 UTAH AVE. S. San Francisco, CA 94080 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-24 |
| Decision Date | 1990-01-22 |