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510(k) K770872

IMPRESSION MATERIAL, ALGINATE by Espe GmbH (Us) — Product Code ELN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1977
Date Received
May 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Preformed Gold Denture
Device Class
Class I
Regulation Number
872.3580
Review Panel
DE
Submission Type

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