The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Complete Brand Comfortplus Multi-purpose Solution.
Device ID | K000164 |
510k Number | K000164 |
Device Name: | COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION |
Classification | Accessories, Soft Lens Products |
Applicant | ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
Contact | Paul J Nowacki |
Correspondent | Paul J Nowacki ALLERGAN, INC. 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-19 |
Decision Date | 2000-06-02 |