FDA 510(k) Application Details - K032125

Device Classification Name Clamp, Vascular

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510(K) Number K032125
Device Name Clamp, Vascular
Applicant VASCULAR CONTROL SYSTEMS, INC
32236 PASEO ADELANTO, STE. E
SAN JUAN CAPISTRANO, CA 92675 US
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Contact KATHLEEN ROBERTS
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 07/10/2003
Decision Date 02/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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