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FDA 510(k) Application Details - K171793
Device Classification Name
Sleeve, Limb, Compressible
More FDA Info for this Device
510(K) Number
K171793
Device Name
Sleeve, Limb, Compressible
Applicant
Bio Compression Systems, Inc.
120 W Commercial Ave
Moonachie, NJ 07074 US
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Contact
Barbara J. Whitman
Other 510(k) Applications for this Contact
Regulation Number
870.5800
More FDA Info for this Regulation Number
Classification Product Code
JOW
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More FDA Info for this Product Code
Date Received
06/16/2017
Decision Date
08/17/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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