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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K914968
Device Name DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR
Applicant
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact SANDRA V.DIGGS
Correspondent
ETHICON, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact SANDRA V.DIGGS
Regulation Number884.1720
Classification Product Code
HET  
Date Received11/05/1991
Decision Date 02/03/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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