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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 K030401
Device Name DISPOSABLE M2-PE MICROKERATOME BLADES
Applicant
OASIS MEDICAL, INC.
512 S. VERMONT AVE.
GLENDORA,  CA  91741 -6205
Applicant Contact YVONNE FERNANDEZ
Correspondent
OASIS MEDICAL, INC.
512 S. VERMONT AVE.
GLENDORA,  CA  91741 -6205
Correspondent Contact YVONNE FERNANDEZ
Regulation Number886.4370
Classification Product Code
HNO  
Date Received02/06/2003
Decision Date 06/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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