The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Disposable Perforator, Model(s) 26-1222, 26-1223.
| Device ID | K071931 |
| 510k Number | K071931 |
| Device Name: | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Emily E Valerio |
| Correspondent | Emily E Valerio Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-13 |
| Decision Date | 2007-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780513612 | K071931 | 000 |
| 10381780513605 | K071931 | 000 |
| 10886704005124 | K071931 | 000 |
| 10886704005117 | K071931 | 000 |