FDA 510(k) Application Details - K061967

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K061967
Device Name Sleeve, Limb, Compressible
Applicant COMPRESSION THERAPY CONCEPTS, INC.
1750 BRIELLE AVE.
SUITE B6
WANAMASSA, NJ 07712 US
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Contact LEN NASS
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 07/12/2006
Decision Date 09/25/2006
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 K061967


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