K832680 is an FDA 510(k) clearance for the MICRO-EDGE DISPOSABLE BLADES. This device is classified as a Instrument, Surgical, Disposable (Class I - General Controls, product code KDC).
Submitted by Micromedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1983, 66 days after receiving the submission on August 9, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K832680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1983 |
| Decision Date | October 14, 1983 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KDC — Instrument, Surgical, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |