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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Manual
510(k) Number K923877
Device Name TONOSHIELD TONOMETER SHIELD
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 Number886.1930
Classification Product Code
HKY  
Date Received08/03/1992
Decision Date 09/30/1992
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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