FDA 510(k) Application Details - K102732

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K102732
Device Name Sleeve, Limb, Compressible
Applicant COMPRESSION THERAPY CONCEPTS
35 JAMES WAY
EATONTOWN, NJ 07724 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 09/22/2010
Decision Date 10/19/2010
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 K102732


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