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510(k) K041718

KELES FACEMASK by Great Lakes Orthodontics, Ltd. — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2004
Date Received
June 24, 2004
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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