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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heparin, Vascular Access Flush
510(k) Number K092938
Device Name HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
Applicant
APP PHARMACEUTICALS, LLC
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
APP PHARMACEUTICALS, LLC
962 ALLEGRO LN.
APOLLO BEACH,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number880.5200
Classification Product Code
NZW  
Date Received09/24/2009
Decision Date 06/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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