510(k) K961275

SIRIUS 10, 10L, 40, 40L by Micro-Mega Societe Anonyme — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
April 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type