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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 K150400
Device Name Renu Gel
Applicant
Cytophil, Inc.
2485 Corporate Circle Suite 2
East Troy,  WI  53120
Applicant Contact BOB VOIGTS
Correspondent
Cytophil, Inc.
2485 Corporate Circle Suite 2
East Troy,  WI  53120
Correspondent Contact BOB VOIGTS
Regulation Number874.3620
Classification Product Code
MIX  
Date Received02/18/2015
Decision Date 04/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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