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FDA 510(k) Application Details - K132360
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K132360
Device Name
Sleeve, Limb, Compressible
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFIELD, MA 02048 US
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Contact
ASHLEY GONCALO
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
07/30/2013
Decision Date
08/27/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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