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FDA 510(k) Application Details - K960431
Device Classification Name
Set, Administration, Intravascular
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510(K) Number
K960431
Device Name
Set, Administration, Intravascular
Applicant
SCIENTIFIC DEVICE MANUFACTURER LLC.
999 ANDERSEN DRIVE, SUITE 120
SAN RAFAEL, CA 94901 US
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Contact
RICHARD C BALL
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Regulation Number
880.5440
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Classification Product Code
FPA
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More FDA Info for this Product Code
Date Received
01/31/1996
Decision Date
10/29/1996
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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