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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cup, Eye
510(k) Number K881369
Device Name ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
Applicant
Advantage Diagnostics Corp.
P.O. Box 12428
Tucson,  AZ  85732
Applicant Contact DAN MISENHIMER
Correspondent
Advantage Diagnostics Corp.
P.O. Box 12428
Tucson,  AZ  85732
Correspondent Contact DAN MISENHIMER
Classification Product Code
LXQ  
Date Received04/01/1988
Decision Date 05/13/1988
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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