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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 K954627
Device Name ECTRA II LIGAMENT RELEASE SYSTEM
Applicant
Smith & Nephew Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Applicant Contact ELIZABETH A RYAN
Correspondent
Smith & Nephew Dyonics, Inc.
160 Dascomb Rd.
Andover,  MA  01810
Correspondent Contact ELIZABETH A RYAN
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/06/1995
Decision Date 12/18/1995
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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