K873786 is an FDA 510(k) clearance for the SMITH & NEPHEW DAYLIGHTER(TM). This device is classified as a Light, Surgical, Ceiling Mounted (Class II - Special Controls, product code FSY).
Submitted by Smith & Nephew, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 23, 1987, 36 days after receiving the submission on September 17, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K873786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1987 |
| Decision Date | October 23, 1987 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FSY — Light, Surgical, Ceiling Mounted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |