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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K840642
Device Name THERMOCRAFT PORCELAIN
Applicant
American Thermocraft Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Thermocraft Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.3920
Classification Product Code
ELL  
Date Received02/15/1984
Decision Date 03/30/1984
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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