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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 K022205
Device Name DISPOSABLE N-PE MICROKERATOME BLADES
Applicant
OASIS MEDICAL, INC.
514 SOUTH VERMONT AVE.
GLENDORA,  CA  91741
Applicant Contact YVONNE FERNANDEZ
Correspondent
OASIS MEDICAL, INC.
514 SOUTH VERMONT AVE.
GLENDORA,  CA  91741
Correspondent Contact YVONNE FERNANDEZ
Regulation Number886.4370
Classification Product Code
HNO  
Date Received07/05/2002
Decision Date 10/03/2002
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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