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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 K951163
Device Name GORE SMOOTHER GUIDED RASP
Applicant
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
P.O. Box 3000
Flagstaff,  AZ  86003
Applicant Contact LARRY J KOVACH
Correspondent
W. L. Gore & Associates, Inc.
1505 N. Fourth St.
P.O. Box 3000
Flagstaff,  AZ  86003
Correspondent Contact LARRY J KOVACH
Regulation Number888.1100
Classification Product Code
HRX  
Date Received03/14/1995
Decision Date 06/01/1995
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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