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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 K003820
Device Name DISPOSABLE CB-PE MICROKERATOME BLADES
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 Received12/11/2000
Decision Date 03/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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