The following data is part of a premarket notification filed by Richards Manufacturer Co. with the FDA for Spectron Extra-small, Straight Femoral.
| Device ID | K831884 |
| 510k Number | K831884 |
| Device Name: | SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | RICHARDS MANUFACTURER CO. 1450 Brooks Road Memphis, NE 38116 |
| Contact | Robert F. Games |
| Correspondent | Robert F Games RICHARDS MANUFACTURER CO. Memphis, TN 38116 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-13 |
| Decision Date | 1983-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010466761 | K831884 | 000 |