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FDA 510(k) Application Details - K101280
Device Classification Name
Oximeter, Reprocessed
More FDA Info for this Device
510(K) Number
K101280
Device Name
Oximeter, Reprocessed
Applicant
MIDWEST REPROCESSING CENTER LLC
434 INDUSTRIAL LANE
BIRMINGHAM, AL 35211 US
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Contact
JEROME JAMES
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
NLF
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More FDA Info for this Product Code
Date Received
05/06/2010
Decision Date
10/07/2010
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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