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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K010872
Device Name ML BLADE, MODEL ML7030
Applicant
MED-LOGICS, INC.
27881 LA PAZ #G316
LAGUNA NIGUEL,,  CA  92677
Applicant Contact GARY MOCNIK
Correspondent
MED-LOGICS, INC.
27881 LA PAZ #G316
LAGUNA NIGUEL,,  CA  92677
Correspondent Contact GARY MOCNIK
Regulation Number886.4370
Classification Product Code
HNO  
Date Received03/23/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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