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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 K032297
Device Name DISPOSABLE N-PE MICKROKERATOME BLADES
Applicant
Oasis Medical, Inc.
512 S. Vermont Ave.
Glendora,  CA  91741
Applicant Contact YVONNE FERNANDEZ
Correspondent
Oasis Medical, Inc.
512 S. Vermont Ave.
Glendora,  CA  91741
Correspondent Contact YVONNE FERNANDEZ
Regulation Number886.4370
Classification Product Code
HNO  
Date Received07/25/2003
Decision Date 08/26/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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