The following data is part of a premarket notification filed by Alcon Surgical, Inc. with the FDA for Retinal Taak.
Device ID | K901275 |
510k Number | K901275 |
Device Name: | RETINAL TAAK |
Classification | Clip, Tantalum, Ophthalmic |
Applicant | ALCON SURGICAL, INC. 17701 COWAN AVE. Irvine, CA 92713 |
Contact | Dave Krapf |
Correspondent | Dave Krapf ALCON SURGICAL, INC. 17701 COWAN AVE. Irvine, CA 92713 |
Product Code | HQW |
CFR Regulation Number | 886.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-19 |
Decision Date | 1990-03-23 |