K903412 is an FDA 510(k) clearance for the STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.. This device is classified as a Microscope, Surgical (Class I - General Controls, product code EPT).
Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 20, 1990, 52 days after receiving the submission on July 30, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K903412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1990 |
| Decision Date | September 20, 1990 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | EPT — Microscope, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |