The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Cosgrove Mitral Valve Retractor.
| Device ID | K844177 |
| 510k Number | K844177 |
| Device Name: | COSGROVE MITRAL VALVE RETRACTOR |
| Classification | Retractor |
| Applicant | KAPP SURGICAL INSTRUMENT, INC. 2888 DETROIT AVE. Cleveland, OH 44113 |
| Contact | Albert E Santilli |
| Correspondent | Albert E Santilli KAPP SURGICAL INSTRUMENT, INC. 2888 DETROIT AVE. Cleveland, OH 44113 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-25 |
| Decision Date | 1984-11-08 |