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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 K952168
Device Name TITANIUM MANDIBULAR FRACTURE SYSTEM
Applicant
Medicon, Inc.
Gansacker 15
D-78532/Tuttlingen,  DE
Applicant Contact SABINE HILSENBECK
Correspondent
Medicon, Inc.
Gansacker 15
D-78532/Tuttlingen,  DE
Correspondent Contact SABINE HILSENBECK
Regulation Number872.4760
Classification Product Code
JEY  
Date Received05/08/1995
Decision Date 06/22/1995
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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