FDA 510(k) Application Details - K152525

Device Classification Name Clamp, Vascular

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510(K) Number K152525
Device Name Clamp, Vascular
Applicant TERUMO MEDICAL CORPORATION
950 ELKTON BLVD
ELKTON, MD 21921 US
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Contact LIANG LU
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 09/03/2015
Decision Date 11/10/2015
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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