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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K840286
Device Name BROOKER EXTERNAL FIXATION FRAME
Applicant
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Depuy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3040
Classification Product Code
JDW  
Date Received01/24/1984
Decision Date 02/09/1984
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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