GLUSITE, MODEL GLU002— 510(k) K013446

Substantially Equivalent

Glustitch, Inc.

FDA 510(k) clearance K013446 for GLUSITE, MODEL GLU002, Substantially Equivalent on 2001-12-20. 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: 2001-10-17
Decision date: 2001-12-20
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.