The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Bfw Wehmerlite Iv-a Fiber Optic Surg. Headlight.
| Device ID | K921848 |
| 510k Number | K921848 |
| Device Name: | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT |
| Classification | Light, Surgical, Instrument |
| Applicant | ALM SURGICAL EQUIPMENT, INC. 3323 WEST WARNER AVE. Santa Ana, CA 92704 |
| Contact | Susan Nielsen |
| Correspondent | Susan Nielsen ALM SURGICAL EQUIPMENT, INC. 3323 WEST WARNER AVE. Santa Ana, CA 92704 |
| Product Code | FSQ |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1992-10-01 |