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FDA 510(k) Application Details - K973107
Device Classification Name
Set, Administration, Intravascular
More FDA Info for this Device
510(K) Number
K973107
Device Name
Set, Administration, Intravascular
Applicant
AMSINO INTL., INC.
833 TOWNE CENTER DR.
POMONA, CA 91767 US
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Contact
RICHARD Y LI
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
08/19/1997
Decision Date
10/02/1997
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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