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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 K931539
Device Name NORMED TITANIUM MINIPLATE SYSTEM
Applicant
Normed Medizin-Technik GmbH
727 Twenty-Third St. S.
Arlington,  VA  22202
Applicant Contact ANDREW E TAYLOR
Correspondent
Normed Medizin-Technik GmbH
727 Twenty-Third St. S.
Arlington,  VA  22202
Correspondent Contact ANDREW E TAYLOR
Regulation Number872.4760
Classification Product Code
JEY  
Date Received03/29/1993
Decision Date 07/05/1994
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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