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510(k) K892806

TUF-COAT by G-C Intl. Corp. — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
April 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

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  • K880848 — FUJI CAP II CAPSULE & APPLIER (May 16, 1988)

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