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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Polymethylmethacrylate)
510(k) Number K863974
Device Name CHARTER LABORATORIES INC. LENS LUBRICANT
Applicant
Paco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood,  NJ  08701
Applicant Contact JOANNE B MARRIOTT
Correspondent
Paco Pharmaceutical Services, Inc.
1200 Paco Way
Bldg. 19
Lakewood,  NJ  08701
Correspondent Contact JOANNE B MARRIOTT
Classification Product Code
HPX  
Date Received10/14/1986
Decision Date 11/10/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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