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510(k) K973542

MASKY by Pressing DI Monticelli Rag. Stefano — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1998
Date Received
September 18, 1997
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

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