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FDA 510(k) Application Details - K993147
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K993147
Device Name
Set, Administration, Intravascular
Applicant
THE KIPP GROUP
930 WANAMAKER AVE.
ONTARIO, CA 91761 US
Other 510(k) Applications for this Company
Contact
GARY WERSCHMIDT
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
09/21/1999
Decision Date
11/02/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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