The following data is part of a premarket notification filed by Allergan Optical with the FDA for Duraclean Daily Cleaner.
Device ID | K881987 |
510k Number | K881987 |
Device Name: | DURACLEAN DAILY CLEANER |
Classification | Accessories, Soft Lens Products |
Applicant | ALLERGAN OPTICAL 2525 DUPONT DR. P.O. BOX 19534 Irvine, CA 92623 -9534 |
Contact | Takruri, Phd |
Correspondent | Takruri, Phd ALLERGAN OPTICAL 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 | 1988-05-11 |
Decision Date | 1988-06-09 |