FDA 510(k) Application Details - K000147

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K000147
Device Name Sleeve, Limb, Compressible
Applicant COMPRESSION THERAPY CONCEPTS, INC.
3614 KENNEDY RD.
SOUTH PLAINFIELD, NJ 07080 US
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Contact J. JAMES BRITTON
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 01/18/2000
Decision Date 04/13/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K000147


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