FDA 510(k) Applications for Medical Device Product Code "HMY"
(Keratome, Battery-Powered)

FDA 510(k) Number Applicant Device Name Decision Date
K023092 BECTON DICKINSON & CO. BD K-4000 MICROKERATOME SYSTEM 10/18/2002
K022637 BECTON DICKINSON & CO. BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME 10/16/2002
K992687 INDUSTRIAL & MEDICAL DESIGN, INC. MILLENIUM MICROKERATOME, MODEL IMD-001 09/24/1999
K974243 INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. KERATOME SYSTEM 01/20/1998
K984537 INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. KERATOME SYSTEM, MODEL K3000 05/14/1999
K022560 MORIA S.A. M2 SINGLE USE MICROKERTOME 09/27/2002
K040297 MORIA S.A. ONEUSE- PLUS MICROKERATOME 03/31/2004
K002191 MORIA, INC. CARRIAZO BARRAQUER II MICROKERATOME 10/12/2000
K981741 MORIA, INC. CARRIAZO BARRAQUER MICROKERATOME 07/24/1998
K003594 MORIA, INC. CARRIAZO BARRAQUER SINGLE USE MICROKERATOME 03/09/2001


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