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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 K020999
Device Name MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
Applicant
Medefil, Inc.
492 Lunt Ave.
Schaumburg,  IL  60193
Applicant Contact PRADEEP AGGARWAL
Correspondent
Medefil, Inc.
492 Lunt Ave.
Schaumburg,  IL  60193
Correspondent Contact PRADEEP AGGARWAL
Regulation Number880.5200
Classification Product Code
NGT  
Date Received03/28/2002
Decision Date 06/20/2002
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 No
Predetermined Change
Control Plan Authorized		 No
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