K933894 is an FDA 510(k) clearance for the DISPOSABLE PERFORATOR. This device is classified as a Drills, Burrs, Trephines & Accessories (compound, Powered) (Class II - Special Controls, product code HBF).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on December 10, 1993, 122 days after receiving the submission on August 10, 1993.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4305.
| 510(k) Number | K933894 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1993 |
| Decision Date | December 10, 1993 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBF - Drills, Burrs, Trephines & Accessories (compound, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4305 |