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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name image, illumination, fiberoptic, for endoscope
510(k) Number K994084
Device Name SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
Applicant
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact JANICE HASELTON
Correspondent
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact JANICE HASELTON
Regulation Number876.1500
Classification Product Code
FFS  
Date Received12/03/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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