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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tonometer, ac-powered
510(k) Number K953031
Device Name ZEIMER SELF TONOMETER
Applicant
CDS TECHNOLOGIES
396 FENTON LN.
P.O. BOX 370
W. CHICAGO,  IL  60186 -0370
Applicant Contact GEORGE JOST
Correspondent
CDS TECHNOLOGIES
396 FENTON LN.
P.O. BOX 370
W. CHICAGO,  IL  60186 -0370
Correspondent Contact GEORGE JOST
Regulation Number886.1930
Classification Product Code
HKX  
Date Received05/24/1995
Decision Date 08/22/1995
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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