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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 K021937
Device Name TGDC-01 PRA
Applicant
Truevision Instruments
4220 Cesar Chavez #536
San Francisco,  CA  94131
Applicant Contact RALF THOMAIER
Correspondent
Truevision Instruments
4220 Cesar Chavez #536
San Francisco,  CA  94131
Correspondent Contact RALF THOMAIER
Regulation Number886.1930
Classification Product Code
HKX  
Date Received06/12/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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