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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 K914963
Device Name SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET
Applicant
Smith & Nephew Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact ERIC BANNON
Correspondent
Smith & Nephew Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact ERIC BANNON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received11/05/1991
Decision Date 06/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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