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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K972154
Device Name COHEN DISTRACTOR
Applicant
Howmedica Leibinger, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact JOHN F DICHIARA
Correspondent
Howmedica Leibinger, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact JOHN F DICHIARA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/09/1997
Decision Date 08/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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