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FDA 510(k) Application Details - K110076
Device Classification Name
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510(K) Number
K110076
Device Name
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE, MN 55369-5562 US
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Contact
GARRETT AHLBORG
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Regulation Number
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Classification Product Code
OWQ
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Date Received
01/11/2011
Decision Date
08/18/2011
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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