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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 K863147
Device Name GLENOID DRILL
Applicant
BOWEN & COMPANY, INC.
1800 CHAPMAN AVE.
ROCKVILLE,  MD  20852
Applicant Contact CARL APPLE
Correspondent
BOWEN & COMPANY, INC.
1800 CHAPMAN AVE.
ROCKVILLE,  MD  20852
Correspondent Contact CARL APPLE
Regulation Number888.4540
Classification Product Code
HTW  
Date Received08/15/1986
Decision Date 09/05/1986
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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