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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 K121795
Device Name CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
Original Applicant
CYTOPHIL INC
2485 corporate circle
suite 2
east troy,  WI  53120
Original Contact bill hubbard
Regulation Number874.3620
Classification Product Code
MIX  
Date Received06/19/2012
Decision Date 02/22/2013
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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