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510(k) K091065

AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 by J. Morita USA, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2009
Date Received
April 14, 2009
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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