K921848 is an FDA 510(k) clearance for the BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT. This device is classified as a Light, Surgical, Instrument (Class II — Special Controls, product code FSQ).
Submitted by Alm Surgical Equipment, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 1, 1992, 167 days after receiving the submission on April 17, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K921848 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 1992 |
| Decision Date | October 01, 1992 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FSQ — Light, Surgical, Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |