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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Passer, Wire, Orthopedic
510(k) Number K863148
Device Name BOWEN KNOT PASSER
Applicant
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Applicant Contact CAROL APPLE
Correspondent
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Correspondent Contact CAROL APPLE
Regulation Number888.4540
Classification Product Code
HXI  
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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