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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 K914483
Device Name WETTING SOLUTION FOR HARD CONTACT LENSES
Applicant
Optopics Laboratories Corp.
P.O. Box 210
Fairton,  NJ  08320
Applicant Contact SCOTT H NICHOLAS
Correspondent
Optopics Laboratories Corp.
P.O. Box 210
Fairton,  NJ  08320
Correspondent Contact SCOTT H NICHOLAS
Regulation Number886.5928
Classification Product Code
LPN  
Date Received10/08/1991
Decision Date 02/05/1992
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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