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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Arthroscope
510(k) Number K051326
Device Name SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM
Applicant
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Applicant Contact JANICE HASELTON
Correspondent
SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER,  MA  01810
Correspondent Contact JANICE HASELTON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/20/2005
Decision Date 06/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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