FDA 510(k) Application Details - K143589

Device Classification Name Device,Anastomotic,Microvascular

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510(K) Number K143589
Device Name Device,Anastomotic,Microvascular
Applicant Synovis Life Technologies, Inc.
2575 University Ave. West, Suite 180
St. Paul, MN 55114 US
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Contact Jodi Jorgenson
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Regulation Number 000.0000

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Classification Product Code MVR
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Date Received 12/18/2014
Decision Date 01/16/2015
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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