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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 K922519
Device Name MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY
Applicant
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact JEFFREY GREEN
Correspondent
Smith & Nephew, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact JEFFREY GREEN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/13/1992
Decision Date 03/29/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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