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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K993515
Device Name MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L
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
FOZ  
Date Received10/18/1999
Decision Date 02/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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