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FDA 510(k) Application Details - K043423
Device Classification Name
Sleeve, Limb, Compressible
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510(K) Number
K043423
Device Name
Sleeve, Limb, Compressible
Applicant
BIO COMPRESSION SYSTEMS, INC.
120 WEST COMMERCIAL AVE.
MOONACHIE, NJ 07074 US
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RON MOTHERWELL
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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
12/13/2004
Decision Date
02/01/2005
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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