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510(k) K883120

FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE by Flexmedics — Product Code EJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1988
Date Received
July 26, 1988
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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