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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K091583
Device Name MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
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
NGT  
Date Received06/02/2009
Decision Date 01/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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