FDA 510(k) Application Details - K073013

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K073013
Device Name Sleeve, Limb, Compressible
Applicant COMPRESSION TECHNOLOGIES UNLIMITED, INC.
12080 DAWNHAVEN AVE.
LANSING, MI 48917 US
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Contact DOUGLASS HALE
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 10/25/2007
Decision Date 11/21/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review

FDA Source Information for K073013


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