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FDA 510(k) Application Details - K082027
Device Classification Name
Set, Administration, Intravascular
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510(K) Number
K082027
Device Name
Set, Administration, Intravascular
Applicant
GENESIS BPS LLC
65 COMMERCE WAY
HACKENSACK, NJ 07601 US
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Contact
CAROLYN AMDITIS
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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
07/17/2008
Decision Date
02/13/2009
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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