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FDA 510(k) Application Details - K071763
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K071763
Device Name
Sleeve, Limb, Compressible
Applicant
CONVATEC
200 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
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Contact
MARILYN KONICKY
Other 510(k) Applications for this Contact
Regulation Number
870.5800
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Classification Product Code
JOW
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More FDA Info for this Product Code
Date Received
06/29/2007
Decision Date
03/07/2008
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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