FDA 510(k) Applications for Medical Device Product Code "NEA"
(Cement, Ear, Nose And Throat)

FDA 510(k) Number Applicant Device Name Decision Date
K003567 CORINTHIAN MEDICAL LTD. SERENOCEM, MODEL BC 010 02/12/2001
K080032 ENVOY MEDICAL CORPORATION ENVOYCEM, MODEL 1640 02/28/2008
K011338 OTOTECH, INC. OTO-CEM 09/13/2001
K140644 OTOTRONIX, LLC PROCEM 06/19/2014
K060750 STRYKER CMF STRYKER INJECTABLE CEMENT 04/19/2006
K042516 WALTER LORENZ SURGICAL, INC. OTOMIMIX 11/08/2004


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