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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Intranasal Septal
510(k) Number K172179
Device Name Chitogel Endoscopic Sinus Surgery Kit
Applicant
Chitogel, Ltd.
139 Moray Place
Dunedin,  NZ 9016
Applicant Contact Caty Spencer
Correspondent
Regulatory Strategies, Inc.
3924 Cascade Beach Rd.
Lutsen,  MN  55612
Correspondent Contact Gregory Mathison
Regulation Number874.4780
Classification Product Code
LYA  
Date Received07/19/2017
Decision Date 10/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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