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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
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
Correspondent 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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