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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
Model CATAOLOG NUMBERING SCHEME FOLLIOWING 08-XXX- YY-VZZ, WHERE XXX = PROUDCT VOLUME FROM 0.5CC TO 1.5CC, WHERE YY = PARTICLE
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 (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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