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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K093402
Device Name AUTOSUTURE EEA ORVIL
Applicant
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact REBECCA RONNER
Correspondent
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact REBECCA RONNER
Regulation Number878.4750
Classification Product Code
GDW  
Date Received11/02/2009
Decision Date 11/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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