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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 K092491
Device Name MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
Applicant
Medefil, Inc.
250 Windy Point Dr.
Glendale Heights,  IL  60139
Applicant Contact PRADEEP AGGARWAL
Correspondent
Medefil, Inc.
250 Windy Point Dr.
Glendale Heights,  IL  60139
Correspondent Contact PRADEEP AGGARWAL
Regulation Number880.5200
Classification Product Code
NZW  
Date Received08/13/2009
Decision Date 02/03/2010
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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