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FDA 510(k) Application Details - K003254
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K003254
Device Name
Set, Administration, Intravascular
Applicant
MISSION MEDICL DEVICES
3525 DEL MAR HEIGHTS RD. #430
SAN DIEGO, CA 92130 US
Other 510(k) Applications for this Company
Contact
DONALD V CANAL
Other 510(k) Applications for this Contact
Regulation Number
880.5440
More FDA Info for this Regulation Number
Classification Product Code
FPA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2000
Decision Date
07/09/2001
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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