M2 SINGLE USE MICROKERTOME


Device Classification Name

keratome, battery-powered

510(k) Number K022560
Device Name M2 SINGLE USE MICROKERTOME
Original Applicant
MORIA S.A.
15 rue georges besse
antony, 

FR

92160

Original Contact melanie renaud-samiri
Regulation Number 886.4370
Classification Product Code
HMY  
Date Received 08/02/2002
Decision Date 09/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No