PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040— 510(k) K071484

Name: FDA 510(k) clearance K071484
Creator: U.S. Food and Drug Administration
Published: 2007-10-10

Substantially Equivalent

Glustitch, Inc.

FDA 510(k) clearance K071484 for PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040, Substantially Equivalent on 2007-10-10. Applicant: Glustitch, Inc.. Device class: 2.

Clearance details

Applicant: Glustitch, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2007-05-30
Decision date: 2007-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.