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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 K083783
Device Name VF LIQUIGEL
Applicant
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact LOUIS-PIERRE MARCOUX
Correspondent
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact LOUIS-PIERRE MARCOUX
Regulation Number874.3620
Classification Product Code
MIX  
Date Received12/19/2008
Decision Date 09/11/2009
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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