K931675 is an FDA 510(k) clearance for the MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS. This device is classified as a Lamp, Surgical (Class II - Special Controls, product code FTD).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 22, 1994, 322 days after receiving the submission on April 6, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K931675 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1993 |
| Decision Date | February 22, 1994 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTD — Lamp, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |