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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 K140409
Device Name FLENTS PLASTIC EYE WASH CUP
Applicant
Apothecary Products, Inc.
11750 12th Ave. S.
Burnsville,  MN  55337
Applicant Contact JAMES JENKINS
Correspondent
Apothecary Products, Inc.
11750 12th Ave. S.
Burnsville,  MN  55337
Correspondent Contact JAMES JENKINS
Classification Product Code
LXQ  
Date Received02/18/2014
Decision Date 07/09/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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