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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 K930935
Device Name ENDOPATH TISSUE EXTRACTION CANNULA
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 Number876.1500
Classification Product Code
GCJ  
Date Received02/23/1993
Decision Date 04/27/1993
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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