FDA 510(k) Application Details - K052243

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K052243
Device Name Sleeve, Limb, Compressible
Applicant PROACT INC.
543 LONG HILL AVENUE
SHELTON, CT 06484 US
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Contact JOSEPH M AZARY
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 08/17/2005
Decision Date 04/12/2006
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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