K770205 is an FDA 510(k) clearance for the CEMENT CHISELS. This device is classified as a Impactor (Class I - General Controls, product code HWA).
Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 8, 1977, 8 days after receiving the submission on January 31, 1977.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K770205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1977 |
| Decision Date | February 08, 1977 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HWA — Impactor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |