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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 K102632
Device Name ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact RENEE ROWE
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact RENEE ROWE
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/13/2010
Decision Date 10/07/2010
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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