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510(k) K771120

IMPREFLEX ALGINATE IMPRESSION MATERIAL by Espe Dental Products — Product Code LEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
June 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

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  • K771901 — CAPMIX (October 20, 1977)
  • K771889 — UNIOLITE (October 20, 1977)
  • K771119 — PASTES, RESTORATIVE & TINTED, DEBTAL (July 15, 1977)