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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 K201198
Device Name S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable
Applicant
Smith & Nephew
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact Janice Haselton
Correspondent
Smith & Nephew
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Janice Haselton
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/04/2020
Decision Date 07/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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