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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 K952852
Device Name NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
Applicant
CRITICAL DEVICE CORP.
499 NIBUS ST.
BREA,  CA  92621
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
CRITICAL DEVICE CORP.
499 NIBUS ST.
BREA,  CA  92621
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/21/1995
Decision Date 02/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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