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FDA 510(k) Application Details - K061857
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K061857
Device Name
Sleeve, Limb, Compressible
Applicant
BIO COMPRESSION SYSTEMS, INC.
P.O. BOX 470218
BROADVIEW HEIGHTS, OH 44141 US
Other 510(k) Applications for this Company
Contact
JAMES JOCHEN ROGERS
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
06/30/2006
Decision Date
08/01/2006
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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