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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 K950045
Device Name KLS-MARTIN MANDIBULAR FRACTURE/RECONSTRUCTION SYSTEM
Applicant
Karl Leibinger GmbH U. Co. KG
2550 M St. NW
Washington,  DC  20037
Applicant Contact MARK A HELLER
Correspondent
Karl Leibinger GmbH U. Co. KG
2550 M St. NW
Washington,  DC  20037
Correspondent Contact MARK A HELLER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/05/1995
Decision Date 03/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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