FDA 510(k) Application Details - K170958

Device Classification Name Clamp, Vascular

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510(K) Number K170958
Device Name Clamp, Vascular
Applicant Tricol Biomedical Inc.
720 SW Washington Street, Suite 200
Portland, OR 97205 US
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Contact Maire Ni Beilliu
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 03/31/2017
Decision Date 08/29/2017
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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