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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 K033293
Device Name MED-LOGICS, MODEL ML7090
Applicant
MED-LOGICS, INC.
26061 MERIT CIRCLE, SUITE #102
LAGUNA HILLS,  CA  92653
Applicant Contact ROD ROSS
Correspondent
MED-LOGICS, INC.
26061 MERIT CIRCLE, SUITE #102
LAGUNA HILLS,  CA  92653
Correspondent Contact ROD ROSS
Regulation Number886.4370
Classification Product Code
HNO  
Date Received10/14/2003
Decision Date 01/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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