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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Weights, Eyelid, External
510(k) Number K940974
Device Name EYECLOSE EXTERNAL EYELID WEIGHTS
Applicant
Meddev Corp.
P.O. Box 1352
Los Altos,  CA  94023
Applicant Contact JOHN M BLACKMORE
Correspondent
Meddev Corp.
P.O. Box 1352
Los Altos,  CA  94023
Correspondent Contact JOHN M BLACKMORE
Regulation Number886.5700
Classification Product Code
MML  
Date Received03/03/1994
Decision Date 06/08/1994
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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