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FDA 510(k) Application Details - K100446
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K100446
Device Name
Sleeve, Limb, Compressible
Applicant
DEVON MEDICAL INC.
1100 1ST AVENUE
SUITE 100
KING OF PRUSSIA, PA 19406 US
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Contact
RUTH WU
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
02/17/2010
Decision Date
03/05/2010
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
Y
Expedited Review
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