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FDA 510(k) Application Details - K110977
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K110977
Device Name
Sleeve, Limb, Compressible
Applicant
CAREMED SUPPLY, INC.
5905 FAWN LANE
CLEVELAND, OH 44141 US
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Contact
EDWARD A KROLL
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
04/07/2011
Decision Date
08/25/2011
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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