The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Sillicone Mcp.
| Device ID | K022892 |
| 510k Number | K022892 |
| Device Name: | ASCENSION SILLICONE MCP |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin, TX 78754 -3832 |
| Contact | Robert M Wolfarth |
| Correspondent | Robert M Wolfarth ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin, TX 78754 -3832 |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-30 |
| Decision Date | 2002-11-25 |
| Summary: | summary |