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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 K991323
Device Name SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
Applicant
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact DEBORAH CONNORS
Correspondent
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact DEBORAH CONNORS
Regulation Number876.1500
Classification Product Code
FFS  
Subsequent Product Code
GCJ  
Date Received04/19/1999
Decision Date 07/06/1999
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
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