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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 K001176
Device Name DISPOSABLE MICROKERATOME BLADES-PE
Applicant
OASIS MEDICAL, INC.
514 S. VERMONT AVE.
GLENDORA,  CA  91741
Applicant Contact YVONNE FERNANDEZ
Correspondent
OASIS MEDICAL, INC.
514 S. VERMONT AVE.
GLENDORA,  CA  91741
Correspondent Contact YVONNE FERNANDEZ
Regulation Number886.4370
Classification Product Code
HNO  
Date Received04/11/2000
Decision Date 09/21/2000
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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