CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT


Device Classification Name

system, vocal cord medialization

510(k) Number K121795
Device Name CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
Applicant
CYTOPHIL INC
2485 corporate circle
suite 2
east troy, 
WI 
53120

Applicant Contact bill hubbard
Correspondent
CYTOPHIL INC
2485 corporate circle
suite 2
east troy, 
WI 
53120

Correspodent Contact bill hubbard
Regulation Number 874.3620
Classification Product Code
MIX  
Date Received 06/19/2012
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