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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Inserter/Remover Contact Lens
510(k) Number K850983
Device Name MARLIN SOFT LENS TWEEZER
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
Regulation Number886.5420
Classification Product Code
KYE  
Date Received03/11/1985
Decision Date 09/10/1985
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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