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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K990723
Device Name DYONICS VARICOSE VEIN ABLATION BLADE
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 Number878.4400
Classification Product Code
GEI  
Date Received03/05/1999
Decision Date 10/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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