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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K990496
Device Name ANESFLOW-DUAL DRIP IV INFUSION SET
Applicant
INNOVATIVE DESIGN ASSOC.
561 EAST SADDLE RIVER
UPPER SADDLE RIVER,  NJ  07458
Applicant Contact JERRY D VLOKA
Correspondent
INNOVATIVE DESIGN ASSOC.
561 EAST SADDLE RIVER
UPPER SADDLE RIVER,  NJ  07458
Correspondent Contact JERRY D VLOKA
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/17/1999
Decision Date 07/01/1999
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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