K852951 is an FDA 510(k) clearance for the WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS. This device is classified as a Light Source, Fiberoptic, Routine (Class II - Special Controls, product code FCW).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on August 27, 1985, 47 days after receiving the submission on July 11, 1985.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K852951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 1985 |
| Decision Date | August 27, 1985 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |