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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heat Source For Bleaching Teeth
510(k) Number K884937
Device Name BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
Applicant
Grass-Telefactor Product Group
Union Hill Bldg., Dehaven St.
W. Conshohocken,  PA  19428
Applicant Contact JOHN B CHATTEN
Correspondent
Grass-Telefactor Product Group
Union Hill Bldg., Dehaven St.
W. Conshohocken,  PA  19428
Correspondent Contact JOHN B CHATTEN
Regulation Number872.6475
Classification Product Code
EEG  
Date Received11/28/1988
Decision Date 04/14/1989
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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