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FDA 510(k) Application Details - K041127
Device Classification Name
Oximeter, Reprocessed
More FDA Info for this Device
510(K) Number
K041127
Device Name
Oximeter, Reprocessed
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MINNEAPOLIS, MN 55369 US
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Contact
BRUCE LESTER
Other 510(k) Applications for this Contact
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
04/30/2004
Decision Date
09/23/2004
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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