MEDLOGICS ML 4000, MODEL 4000


information about

Device Classification Name

keratome, ac-powered

510(k) Number K002515
Device Name MEDLOGICS ML 4000, MODEL 4000
Original Applicant
MED-LOGICS, INC.
30001 golden lantern #334
laguna niguel, 
CA 
92677

Original Contact gary mocnik
Regulation Number 886.4370
Classification Product Code
HNO  
Date Received 08/15/2000
Decision Date 02/22/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No