The following data is part of a premarket notification filed by Anago, Inc. with the FDA for U.c.e.z. Lens Cleaner Kit.
Device ID | K925659 |
510k Number | K925659 |
Device Name: | U.C.E.Z. LENS CLEANER KIT |
Classification | Anti Fog Solution And Accessories, Endoscopy |
Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Contact | Jill D Albritton |
Correspondent | Jill D Albritton ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
Product Code | OCT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-07 |
Decision Date | 1993-09-17 |