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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K882384
Device Name DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
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 Number886.5928
Classification Product Code
LRX  
Date Received06/09/1988
Decision Date 06/23/1989
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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