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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 K980604
Device Name SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES
Applicant
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact DEBORAH J CONNORS
Correspondent
SMITH & NEPHEW, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact DEBORAH J CONNORS
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/17/1998
Decision Date 05/19/1998
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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