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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K884257
Device Name LEVINIUM
Applicant
Ticomet Engineering & Consulting
4449 Chesswick Dr.
Cincinnati,  OH  45242
Applicant Contact DAVID J LEVINE
Correspondent
Ticomet Engineering & Consulting
4449 Chesswick Dr.
Cincinnati,  OH  45242
Correspondent Contact DAVID J LEVINE
Regulation Number872.3710
Classification Product Code
EJH  
Date Received10/11/1988
Decision Date 12/22/1988
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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