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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Schirmer
510(k) Number K881515
Device Name TEAR VOLUME TESTS
Applicant
Visionex, Inc.
1206 Sargent Dr.
Sunnyvale,  CA  94087
Applicant Contact JESSICA AYRES
Correspondent
Visionex, Inc.
1206 Sargent Dr.
Sunnyvale,  CA  94087
Correspondent Contact JESSICA AYRES
Regulation Number886.1800
Classification Product Code
KYD  
Date Received04/11/1988
Decision Date 05/23/1988
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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