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FDA 510(k) Application Details - K012574
Device Classification Name
Clamp, Vascular, Reprocessed
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510(K) Number
K012574
Device Name
Clamp, Vascular, Reprocessed
Applicant
STERILMED, INC.
11400 73RD AVE N., SUITE 100
MAPLE GROVE, MN 55369 US
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Contact
PATRICK FLEISCHHACKER
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Regulation Number
870.4450
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Classification Product Code
NMF
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More FDA Info for this Product Code
Date Received
08/09/2001
Decision Date
07/18/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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