The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Parke-davis Total Knee Prosthesis.
| Device ID | K800363 |
| 510k Number | K800363 |
| Device Name: | PARKE-DAVIS TOTAL KNEE PROSTHESIS |
| Classification | Caliper |
| Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTZ |
| CFR Regulation Number | 888.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-20 |
| Decision Date | 1980-03-10 |