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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stripper, Vein, External
510(k) Number K041453
Device Name SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact KAREN PROVENCHER
Correspondent
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact KAREN PROVENCHER
Regulation Number870.4885
Classification Product Code
DWQ  
Date Received06/01/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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