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510(k) K032392

MORALES PROTRACTION FACEMASK by Ortosim, S.A. DE C.V. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2003
Date Received
August 4, 2003
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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