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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 K870388
Device Name HOFFMANN LEG LENGTHENING PLATE SYSTEM
Applicant
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact ROBERT E SMITH
Correspondent
Howmedica Corp.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact ROBERT E SMITH
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/30/1987
Decision Date 04/03/1987
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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