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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 K092577
Device Name ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75)
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Applicant Contact Abhilasha Mukherjee
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK ROAD
CINCINNATI,  OH  45242
Correspondent Contact Abhilasha Mukherjee
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received08/21/2009
Decision Date 09/15/2009
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
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