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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, phacofragmentation
510(k) Number K943379
Device Name PHACO TIPS FOR PHACO FRAGMENTATION MACHINES
Applicant
OASIS MEDICAL, INC.
514 S. VERMONT AVE.
GLENDORA,  CA  91741
Applicant Contact JAMES CHRISTENSEN
Correspondent
OASIS MEDICAL, INC.
514 S. VERMONT AVE.
GLENDORA,  CA  91741
Correspondent Contact JAMES CHRISTENSEN
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/13/1994
Decision Date 10/11/1994
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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