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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anastomotic, Microvascular
510(k) Number K040163
Device Name MICROVASCULAR ANASTOMOTIC DEVICE
Applicant
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
439 INDUSTRIAL LN.
BIRMINGHAM,  AL  35211 -4464
Applicant Contact DAISY P SIN
Correspondent
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
439 INDUSTRIAL LN.
BIRMINGHAM,  AL  35211 -4464
Correspondent Contact DAISY P SIN
Regulation Number878.4300
Classification Product Code
MVR  
Date Received01/26/2004
Decision Date 04/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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