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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Hand, Calculus Removal
510(k) Number K801974
Device Name ANALYTIC TECH. METAL POINT HEATER #3001
Applicant
Analytic Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Analytic Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.4565
Classification Product Code
ELA  
Date Received08/19/1980
Decision Date 11/12/1980
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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