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FDA 510(k) Application Details - K952852
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K952852
Device Name
Set, Administration, Intravascular
Applicant
CRITICAL DEVICE CORP.
499 NIBUS ST.
BREA, CA 92621 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
880.5440
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Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/1995
Decision Date
02/16/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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