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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K914368
Device Name PART 872 DEGUFILL H & DEGUFILL M DA
Applicant
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Applicant Contact JOE RICHTER
Correspondent
Degussa AG
3950 S. Clinton Ave.
South Plainfield,  NJ  07080
Correspondent Contact JOE RICHTER
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/01/1991
Decision Date 11/13/1991
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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