FDA 510(k) Application Details - K110358

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K110358
Device Name Sleeve, Limb, Compressible
Applicant MICROTEK MEDICAL, INC.
602 LEHMBERG RD.
COLUMBUS, MS 39702 US
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Contact TOM BONNER
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 02/07/2011
Decision Date 05/05/2011
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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