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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Diamond, Dental
510(k) Number K833038
Device Name SUMMA DISK
Applicant
SHOFU DENTAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHOFU DENTAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number872.4535
Classification Product Code
DZP  
Date Received09/06/1983
Decision Date 10/04/1983
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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