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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 K851497
Device Name MARLIN CONTACT LENS CASE
Applicant
Marlin Industries
P.O. Box 284
Tarzana,  CA  91356
Applicant Contact JEROME HIRSCH
Correspondent
Marlin Industries
P.O. Box 284
Tarzana,  CA  91356
Correspondent Contact JEROME HIRSCH
Classification Product Code
HPX  
Date Received04/15/1985
Decision Date 05/16/1985
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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