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
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Regulation Number 000.0000

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Classification Product Code MVR
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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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