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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 K935064
Device Name ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION
Applicant
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact MELISSA WALKER
Correspondent
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact MELISSA WALKER
Regulation Number876.1500
Classification Product Code
OCW  
Date Received10/20/1993
Decision Date 01/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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