K843294 is an FDA 510(k) clearance for the MED. DYNAMICS SATICAN VIDEO CAMERA 5410. This device is classified as a Camera, Surgical And Accessories (Class I - General Controls, product code KQM).
Submitted by Medline Industries, Inc. (Englewood, US). The FDA issued a Cleared decision on December 12, 1984, 113 days after receiving the submission on August 21, 1984.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4160.
| 510(k) Number | K843294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1984 |
| Decision Date | December 12, 1984 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KQM — Camera, Surgical And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4160 |