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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Vocal Cord Medialization
510(k) Number K180631
Device Name Silk Voice
Applicant
Sofregen Medical, Inc.
200 Boston Ave., Suite 1100
Medford,  MA  02155
Applicant Contact Anh Hoang
Correspondent
Sofregen Medical, Inc.
200 Boston Ave., Suite 1100
Medford,  MA  02155
Correspondent Contact Anh Hoang
Regulation Number874.3620
Classification Product Code
MIX  
Date Received03/09/2018
Decision Date 11/08/2018
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
Predetermined Change
Control Plan Authorized		 No
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