The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Duracon Recessed Patella.
| Device ID | K951655 |
| 510k Number | K951655 |
| Device Name: | DURACON RECESSED PATELLA |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-10 |
| Decision Date | 1995-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327101850 | K951655 | 000 |
| 04546540318503 | K951655 | 000 |
| 04546540318480 | K951655 | 000 |