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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 K920752
Device Name ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER
Applicant
ETHICON, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact MELISSA WALKER
Correspondent
ETHICON, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact MELISSA WALKER
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/19/1992
Decision Date 08/06/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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