FDA 510(k) Application Details - K050584

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K050584
Device Name Sleeve, Limb, Compressible
Applicant MEDMARK TECHNOLOGIES, LLC
724H WEST RT 313
PERKASIE, PA 18944 US
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Contact MARK HIGGINS
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 03/07/2005
Decision Date 03/22/2005
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 Y
Expedited Review



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