FDA 510(k) Application Details - K141064

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K141064
Device Name Sleeve, Limb, Compressible
Applicant CAREMED SUPPLY, INC.
NO.45, MINSHENG RD.
DANSHUI TOWN
NEW TAIPEI CITY 251 TW
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Contact MICHAEL LEE
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 04/24/2014
Decision Date 12/04/2014
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 N
Expedited Review



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