K893828 is an FDA 510(k) clearance for the ML-800 AUTOELECTRONIC LIGHT SOURCE. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by M.P. Video, Inc. (Hopkinton, US). The FDA issued a Cleared decision on July 24, 1989, 61 days after receiving the submission on May 24, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K893828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 1989 |
| Decision Date | July 24, 1989 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FST — Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |