K930302 is an FDA 510(k) clearance for the BIRTCHER SURE CLEAN INSTRUMENT SYSTEM. This device is classified as a Laryngoscope, Endoscope (Class II - Special Controls, product code GCI).
Submitted by Birtcher Medical Systems, Inc. (Duluth, US). The FDA issued a Cleared decision on October 27, 1993, 279 days after receiving the submission on January 21, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K930302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 1993 |
| Decision Date | October 27, 1993 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCI — Laryngoscope, Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |