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510(k) K052553

NITOM LOCKING FACEBOW by Russell Samuels Orthodontic Design — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2005
Date Received
September 16, 2005
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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