OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700— 510(k) K042828

Name: FDA 510(k) clearance K042828
Creator: U.S. Food and Drug Administration
Published: 2004-12-01

Substantially Equivalent

Young O/S, LLC

FDA 510(k) clearance K042828 for OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700, Substantially Equivalent on 2004-12-01. Applicant: Young O/S, LLC. Device class: 1.

Clearance details

Applicant: Young O/S, LLC
Product code: Code EKR
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 2004-10-12
Decision date: 2004-12-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Fenton, MO, US

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