FDA 510(k) Application Details - K040649

Device Classification Name Sleeve, Limb, Compressible

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510(K) Number K040649
Device Name Sleeve, Limb, Compressible
Applicant TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact GAIL CHRISTIE
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Regulation Number 870.5800

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Classification Product Code JOW
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Date Received 03/11/2004
Decision Date 07/15/2004
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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