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FDA 510(k) Application Details - K043453
Device Classification Name
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510(K) Number
K043453
Device Name
STERILEMED REPROCESSED IVUS IMAGING CATHETER
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE, MN 55369 US
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BRUCE LESTER
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Regulation Number
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Classification Product Code
OWQ
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Date Received
12/15/2004
Decision Date
03/01/2005
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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