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510(k) K890529

ALASTIGARD by Unitek Corp. — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1989
Date Received
February 2, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bracket, Metal, Orthodontic
Device Class
Class I
Regulation Number
872.5410
Review Panel
DE
Submission Type

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