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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K961235
Device Name SIRIUS 180, 180L, 230, 230L
Applicant
Micro-Mega Societe Anonyme
5-12 Rue Du Tunnel
Besancon,  FR 25006
Applicant Contact JM BADOZ
Correspondent
Micro-Mega Societe Anonyme
5-12 Rue Du Tunnel
Besancon,  FR 25006
Correspondent Contact JM BADOZ
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/29/1996
Decision Date 01/08/1997
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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