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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K920110
Device Name ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE
Applicant
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact SANDRA DIGGS
Correspondent
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact SANDRA DIGGS
Regulation Number878.4800
Classification Product Code
GEA  
Date Received01/07/1992
Decision Date 04/02/1992
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
Predetermined Change
Control Plan Authorized		 No
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