FDA 510(k) Application Details - K133029

Device Classification Name Clamp, Vascular

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510(K) Number K133029
Device Name Clamp, Vascular
Applicant COMPRESSION WORKS, LLC
15 SARGENT AVE
PROVIDENCE, RI 02906 US
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Contact MICHAEL FORSTADT
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/26/2013
Decision Date 12/06/2013
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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