FDA 510(k) Application Details - K131561

Device Classification Name Clamp, Vascular

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510(K) Number K131561
Device Name Clamp, Vascular
Applicant SAM MEDICAL PRODUCTS
27350 SW 95TH AVE STE 3038
Wilsonville, OR 97070 US
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Contact JACK N MCCUTCHEON
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 05/30/2013
Decision Date 07/24/2013
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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