K933310 is an FDA 510(k) clearance for the MICRINS CONTRAST BACKGROUND MATERIAL. This device is classified as a Microscope, Surgical (Class I - General Controls, product code EPT).
Submitted by Micrins Surgical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 19, 1993, 43 days after receiving the submission on July 7, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4700.
| 510(k) Number | K933310 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1993 |
| Decision Date | August 19, 1993 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | EPT — Microscope, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4700 |