FDA 510(k) Application Details - K051438

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K051438
Device Name Sleeve, Limb, Compressible
Applicant ALLIANCE MEDICAL, INC.
10232 SOUTH 51 ST.
PHOENIX, AZ 85044 US
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Contact MOIRA BARTON
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 06/01/2005
Decision Date 04/04/2006
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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