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510(k) K924645

TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS by Unitek Corp. — Product Code JEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1992
Date Received
September 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plier, Orthodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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