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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K895243
Device Name BARNES FEMORAL LENGTHENING DEVICE
Applicant
PIEDMONT SPORTS MEDICINE & ORTHOPAEDIC CLINIC
4660 RIVERSIDE PARK BLVD.
MACON,  GA  31210
Applicant Contact BARNES, JR
Correspondent
PIEDMONT SPORTS MEDICINE & ORTHOPAEDIC CLINIC
4660 RIVERSIDE PARK BLVD.
MACON,  GA  31210
Correspondent Contact BARNES, JR
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/21/1989
Decision Date 08/10/1990
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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