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510(k) K151912

AIR-FLOW handy 3.0 PLUS by E.M.S Electro Medical Systems S.A — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2016
Date Received
July 13, 2015
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

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