K820730 is an FDA 510(k) clearance for the MICRO CISE DIAMOND SCALPEL. This device is classified as a Scalpel, One-piece (Class I - General Controls, product code GDX).
Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on April 9, 1982, 23 days after receiving the submission on March 17, 1982.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K820730 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1982 |
| Decision Date | April 09, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDX — Scalpel, One-piece |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |