The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Disposable Perforator.
| Device ID | K924242 |
| 510k Number | K924242 |
| Device Name: | DISPOSABLE PERFORATOR |
| Classification | Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Carleton Southhworth |
| Correspondent | Carleton Southhworth Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | HBF |
| CFR Regulation Number | 882.4305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-24 |
| Decision Date | 1993-07-08 |