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510(k) K831095

ROYALE II by Factor, Ii, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by Factor, Ii, Inc.

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