The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Rs-cup Acetabular Prosthesis.
| Device ID | K885049 |
| 510k Number | K885049 |
| Device Name: | RS-CUP ACETABULAR PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | ALLO PRO CORP. 1320 STONY BROOK RD. SUITE 220 Stony Brook, NY 11790 |
| Contact | Larry Kluge |
| Correspondent | Larry Kluge ALLO PRO CORP. 1320 STONY BROOK RD. SUITE 220 Stony Brook, NY 11790 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-07 |
| Decision Date | 1989-01-13 |