FDA 510(k) Application Details - K051805

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K051805
Device Name Sleeve, Limb, Compressible
Applicant TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD, MA 02048 US
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Contact BRIDGET GARDNER
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 07/05/2005
Decision Date 10/13/2005
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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