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FDA 510(k) Application Details - K101702
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K101702
Device Name
Sleeve, Limb, Compressible
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
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/17/2010
Decision Date
08/27/2010
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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