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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K003090
Device Name MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM
Applicant
Midmark Corp.
Oute 47 W., Vista Dr.
Versailles,  OH  45380
Applicant Contact MIKE SNYDER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DONALD J SHERRATT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received10/03/2000
Decision Date 10/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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