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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 K970911
Device Name LEE PLATE
Applicant
Howmedica Leibinger, Inc.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Applicant Contact KRISTYN WASKI
Correspondent
Howmedica Leibinger, Inc.
14540 Beltwood Pkwy. E.
Dallas,  TX  75244
Correspondent Contact KRISTYN WASKI
Regulation Number872.4760
Classification Product Code
JEY  
Date Received03/12/1997
Decision Date 04/11/1997
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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