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FDA 510(k) Application Details - K040163
Device Classification Name
Device,Anastomotic,Microvascular
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510(K) Number
K040163
Device Name
Device,Anastomotic,Microvascular
Applicant
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
439 INDUSTRIAL LN.
BIRMINGHAM, AL 35211-4464 US
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Contact
DAISY P SIN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MVR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/26/2004
Decision Date
04/16/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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