The following data is part of a premarket notification filed by C.l. Mcintosh & Assoc., Inc. with the FDA for Oscar Orthosonics System For Cemented Arthroplasty Revision.
| Device ID | K961725 |
| 510k Number | K961725 |
| Device Name: | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | C.L. MCINTOSH & ASSOC., INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan C.L. MCINTOSH & ASSOC., INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-03 |
| Decision Date | 1996-08-01 |
| Summary: | summary |