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510(k) K993224

T-GEAR, MODEL TG/400-700 by Dontech Products B.V. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2000
Date Received
September 27, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type

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