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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K192471
Device Name RHIN1 Stylus
Applicant
Aerin Medical, Inc.
232 E Caribbean Dr.
Sunnyvale,  CA  94089
Applicant Contact Matthew M Hull
Correspondent
Aerin Medical, Inc.
232 E Caribbean Dr.
Sunnyvale,  CA  94089
Correspondent Contact Matthew M Hull
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/10/2019
Decision Date 12/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02914236
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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