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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 K080956
Device Name MODIFICATION TO VF GEL PLUS
Applicant
COAPT SYSTEMS, INC.
1820 EMBARCADERO RD.
PALO ALTO,  CA  94303
Applicant Contact LINDA RUEDY
Correspondent
COAPT SYSTEMS, INC.
1820 EMBARCADERO RD.
PALO ALTO,  CA  94303
Correspondent Contact LINDA RUEDY
Regulation Number874.3620
Classification Product Code
MIX  
Date Received04/03/2008
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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