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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Dental
510(k) Number K926205
Device Name MONOSTERYL
Applicant
Utensili Super Abrasivi
Via Donizetti, 10
20095 Cusano Milanino
(Milan), Italy,  IT
Applicant Contact SUSAN KNOX
Correspondent
Utensili Super Abrasivi
Via Donizetti, 10
20095 Cusano Milanino
(Milan), Italy,  IT
Correspondent Contact SUSAN KNOX
Regulation Number872.3240
Classification Product Code
EJL  
Date Received12/09/1992
Decision Date 02/10/1994
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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