K920641 is an FDA 510(k) clearance for the ALCON OPERATING MICROSCOPES, a Microscope, Operating & Accessories, Ac-powered, Ophthalmic (Class I — General Controls, product code HRM), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on October 9, 1992, 240 days after receiving the submission on February 12, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K920641 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 12, 1992 |
| Decision Date | October 09, 1992 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HRM — Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4700 |