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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 K964918
Device Name NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
Applicant
CRITICAL DEVICE CORP.
499 NIBUS ST.
BREA,  CA  92621
Applicant Contact DAN HYUN
Correspondent
CRITICAL DEVICE CORP.
499 NIBUS ST.
BREA,  CA  92621
Correspondent Contact DAN HYUN
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/09/1996
Decision Date 04/14/1997
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
Recalls CDRH Recalls
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