KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC— 510(k) K983161

Name: FDA 510(k) clearance K983161
Creator: U.S. Food and Drug Administration
Published: 1998-09-30

Substantially Equivalent

Sabre-K , Ltd.

FDA 510(k) clearance K983161 for KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC, Substantially Equivalent on 1998-09-30. Applicant: Sabre-K , Ltd.. Device class: 1.

Clearance details

Applicant: Sabre-K , Ltd.
Product code: Code ELR
Device class: Class 1
Regulation: 21 CFR 872.3810
Advisory panel: Dental
Date received: 1998-09-09
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheshire Wa 15 8ah, GB

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