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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bit, Drill
510(k) Number K915692
Device Name CANNULATED DRILL BIT
Applicant
W. L. Gore & Associates, Inc.
1500 N. Fourth St.
Flagstaff,  AZ  86001
Applicant Contact ANDREW BERMAN
Correspondent
W. L. Gore & Associates, Inc.
1500 N. Fourth St.
Flagstaff,  AZ  86001
Correspondent Contact ANDREW BERMAN
Regulation Number888.4540
Classification Product Code
HTW  
Date Received12/23/1991
Decision Date 01/16/1992
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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