K771005 is an FDA 510(k) clearance for the NEW PODIATRY PRODUCTS. This device is classified as a Instrument, Cutting, Orthopedic (Class I - General Controls, product code HTZ).
Submitted by Dentronix, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1977, 15 days after receiving the submission on June 2, 1977.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K771005 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1977 |
| Decision Date | June 17, 1977 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | HTZ — Instrument, Cutting, Orthopedic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |