K933079 is an FDA 510(k) clearance for the ELECTROCAUTERY SYSTEM MODEL 1980. This device is classified as a Unit, Cautery, Thermal, Battery-powered (Class II - Special Controls, product code HQP).
Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on February 22, 1994, 244 days after receiving the submission on June 23, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4115.
| 510(k) Number | K933079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 244 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQP — Unit, Cautery, Thermal, Battery-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4115 |