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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gutta-Percha
510(k) Number K823486
Device Name TOUCH-N-HEAT MODEL 5001
Applicant
Analytic Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Analytic Technology
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3850
Classification Product Code
EKM  
Date Received11/23/1982
Decision Date 01/18/1983
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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