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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, And Accessories, Dental
510(k) Number K921604
Device Name TOUCH N' HEAT, 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 Number872.4920
Classification Product Code
EKZ  
Date Received03/27/1992
Decision Date 08/24/1992
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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