FDA 510(k) Application Details - K122179

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K122179
Device Name Sleeve, Limb, Compressible
Applicant COMPRESSION THERAPY CONCEPTS
555 INDUSTRIAL WAY WEST
EATONTOWN, NJ 07724-2298 US
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Contact LEONARD NASS
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 07/23/2012
Decision Date 08/20/2012
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

FDA Source Information for K122179


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