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FDA 510(k) Application Details - K142309
Device Classification Name
Device,Anastomotic,Microvascular
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510(K) Number
K142309
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
Troy Thome
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MVR
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More FDA Info for this Product Code
Date Received
08/19/2014
Decision Date
09/16/2014
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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