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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 K011944
Device Name DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088
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 Received06/21/2001
Decision Date 09/19/2001
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
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