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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Soft Lens Products
510(k) Number K881987
Device Name DURACLEAN DAILY CLEANER
Applicant
Allergan Optical
2525 Dupont Dr.
P.O. Box 19534
Irvine,  CA  92623
Applicant Contact TAKRURI, PHD
Correspondent
Allergan Optical
2525 Dupont Dr.
P.O. Box 19534
Irvine,  CA  92623
Correspondent Contact TAKRURI, PHD
Regulation Number886.5928
Classification Product Code
LPN  
Date Received05/11/1988
Decision Date 06/09/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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