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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Caries Detection
510(k) Number K982105
Device Name ORAL POTENTIAL METER (OPM)
Applicant
Pertec of Wisconsin, Inc.
10971 Clinic Rd.
Suring,  WI  54174
Applicant Contact DOUGLAS L COOK
Correspondent
Pertec of Wisconsin, Inc.
10971 Clinic Rd.
Suring,  WI  54174
Correspondent Contact DOUGLAS L COOK
Regulation Number872.1740
Classification Product Code
LFC  
Date Received06/16/1998
Decision Date 09/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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