FDA.reportPublic FDA data

510(k) K043183

Device
EPI-K
Applicant
Moria SA
510(k) number
K043183
Product code
HNO
Decision
Substantially Equivalent (SESE)
Decision date
2005-03-25
Date received
2004-11-17
Regulation
886.4370
Classification name
Keratome, Ac-Powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ELANIE RENAUD-SAMIRI
Address
15 Rue Georges Besse Antony FR 92160 92160

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HNO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbH2009-01-16
K082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KG2008-08-01
K062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.2006-09-06
K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries2006-03-23
K051486NORWOOD ABBEY CENTURION SES EPIKERATOMENorwood Abbey , Ltd.2005-07-06
K043150AMADEUS II EPIKERATOMESis Ltd., Surgical Instrument Systems2005-01-31
K042083MODIFICATION TO VISITOME 20-10 MICROKERATOMEBiovision AG2004-11-16
K042810CENTURION SES EPIKERATOMENorwood Abbey , Ltd.2004-10-28
K041110MB 105 MILLENNIUM BLADESMillennium Biomedical, Inc.2004-10-13
K041206EPITOME SYSTEMGebauer Medizintechnik GmbH2004-09-15
K032910CARRIAZO PENDULARSchwind Eye-Tech-Solutions GmbH & Co. KG2004-08-30
K032836M3 MICROKERATOMEMoria SA2004-06-18
K033457M2 COMPATIBLE MICROKERATOME BLADEMicro Specialties, Inc.2004-05-25