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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 K010489
Device Name DYONICS VISION 111 MOBILE VIDEO UNIT
Applicant
Smith & Nephew, Inc.
3600 NW 138th St.
Oklahoma City,  OK  73134
Applicant Contact STEVEN JACKSON
Correspondent
Smith & Nephew, Inc.
3600 NW 138th St.
Oklahoma City,  OK  73134
Correspondent Contact STEVEN JACKSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/20/2001
Decision Date 04/10/2001
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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