K770301 is an FDA 510(k) clearance for the NIPPER, PSO4 TISSUE. This device is classified as a Cutter, Surgical (Class I - General Controls, product code FZT).
Submitted by Dentronix, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 7, 1977, 19 days after receiving the submission on February 16, 1977.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K770301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1977 |
| Decision Date | March 07, 1977 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FZT — Cutter, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |