FDA 510(k) Application Details - K132727

Device Classification Name Device,Anastomotic,Microvascular

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510(K) Number K132727
Device Name Device,Anastomotic,Microvascular
Applicant SYNOVIS LIFE TECHNOLOGIES, INC.
2575 UNIVERSITY AVE., STE.180
ST. PAUL, MN 55114-1024 US
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Contact TROY THOME
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Regulation Number 000.0000

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Classification Product Code MVR
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Date Received 09/03/2013
Decision Date 10/22/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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