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FDA 510(k) Application Details - K102560
Device Classification Name
Oximeter, Reprocessed
More FDA Info for this Device
510(K) Number
K102560
Device Name
Oximeter, Reprocessed
Applicant
STERILMED, INC.
11400 73RD AVE. N, STE. 100
MAPLE GROVE, MN 55369 US
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Contact
GARRETT AHLBORG
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Regulation Number
870.2700
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Classification Product Code
NLF
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More FDA Info for this Product Code
Date Received
09/07/2010
Decision Date
02/18/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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