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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 K970511
Device Name DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
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 Number888.1100
Classification Product Code
HRX  
Date Received02/11/1997
Decision Date 08/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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