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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 K181696
Device Name ChitoZolve
Applicant
Gyrus ACMI, Inc
136 Turnpike Road
Southborough,  MA  01772
Applicant Contact Dolan Mills
Correspondent
Gyrus ACMI, Inc
136 Turnpike Road
Southborough,  MA  01772
Correspondent Contact Dolan Mills
Regulation Number874.4780
Classification Product Code
LYA  
Subsequent Product Code
EMX  
Date Received06/27/2018
Decision Date 11/30/2018
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
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