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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K970720
Device Name ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact LORRI CHAVEZ
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact LORRI CHAVEZ
Regulation Number876.1500
Classification Product Code
OCW  
Date Received02/27/1997
Decision Date 06/27/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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