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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 K915243
Device Name TOUCH 'N HEAT MODEL 5002, MODIFICATION
Applicant
Analytic Technology
15233 Northeast 90th St.
Redmond,  WA  98052
Applicant Contact JOHAN MASRELIEZ
Correspondent
Analytic Technology
15233 Northeast 90th St.
Redmond,  WA  98052
Correspondent Contact JOHAN MASRELIEZ
Regulation Number872.3850
Classification Product Code
EKM  
Date Received10/31/1991
Decision Date 01/21/1992
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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