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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 K981071
Device Name ML MICROKERATOME
Applicant
MED-LOGICS, INC.
30251 GOLDEN LANTERN
SUITE E-207
LAGUNA NIGUEL,  CA  92677
Applicant Contact BETTY ROSS
Correspondent
MED-LOGICS, INC.
30251 GOLDEN LANTERN
SUITE E-207
LAGUNA NIGUEL,  CA  92677
Correspondent Contact BETTY ROSS
Regulation Number886.4370
Classification Product Code
HNO  
Date Received03/24/1998
Decision Date 07/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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