Chitogel Endoscopic Sinus Surgery Kit— 510(k) K172179

Name: FDA 510(k) clearance K172179
Creator: U.S. Food and Drug Administration
Published: 2017-10-17

Substantially Equivalent

Chitogel, Ltd.

FDA 510(k) clearance K172179 for Chitogel Endoscopic Sinus Surgery Kit, Substantially Equivalent on 2017-10-17. Applicant: Chitogel, Ltd.. Device class: 1.

Clearance details

Applicant: Chitogel, Ltd.
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2017-07-19
Decision date: 2017-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunedin, NZ

Download summary PDF View on FDA.gov ↗

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