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510(k) K951239

GLOWING SPIRITS by Ormco Corp. — Product Code DYW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1995
Date Received
March 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Plastic, Orthodontic
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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