GLUSEAL 90, MODEL GLU9010— 510(k) K083752

Substantially Equivalent

Glustitch, Inc.

FDA 510(k) clearance K083752 for GLUSEAL 90, MODEL GLU9010, Substantially Equivalent on 2009-02-23. Applicant: Glustitch, Inc.. Device class: 1.

Clearance details

Applicant: Glustitch, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2008-12-17
Decision date: 2009-02-23
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.