FDA 510(k) Application Details - K970611

Device Classification Name Clamp, Vascular

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510(K) Number K970611
Device Name Clamp, Vascular
Applicant ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK, CA 94025 US
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Contact ANTHONY DURSO
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 02/18/1997
Decision Date 08/19/1997
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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