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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 K081815
Device Name VOCALIS GEL
Applicant
CYTOPHIL INC
5546 N SANTA MONICA BLVD
WHITEFISH BAY,  WI  53217 -5159
Applicant Contact Greg Johnson
Correspondent
CYTOPHIL INC
5546 N SANTA MONICA BLVD
WHITEFISH BAY,  WI  53217 -5159
Correspondent Contact Greg Johnson
Regulation Number874.3620
Classification Product Code
MIX  
Date Received06/26/2008
Decision Date 01/05/2009
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
Predetermined Change
Control Plan Authorized		 No
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