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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 K872567
Device Name SOFT CONTACT LENS REMOVER
Applicant
Magnivision, Inc.
P.O. Box 817
Miami,  FL  33152
Applicant Contact STEVE FELKOWITZ
Correspondent
Magnivision, Inc.
P.O. Box 817
Miami,  FL  33152
Correspondent Contact STEVE FELKOWITZ
Regulation Number886.5420
Classification Product Code
KYE  
Date Received06/29/1987
Decision Date 08/10/1987
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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