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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K915099
Device Name ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN
Applicant
ETHICON, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact SANDRA V DIGGS
Correspondent
ETHICON, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact SANDRA V DIGGS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/12/1991
Decision Date 03/19/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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