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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 K981432
Device Name GOLDMAN MANUAL TONOMETER
Applicant
Golden Vision, Inc.
7436 SW 117th Ave.,Suite 103
Miami,  FL  33183 -3816
Applicant Contact ANDRES R QUIROZ
Correspondent
Golden Vision, Inc.
7436 SW 117th Ave.,Suite 103
Miami,  FL  33183 -3816
Correspondent Contact ANDRES R QUIROZ
Regulation Number886.1930
Classification Product Code
HKY  
Date Received04/20/1998
Decision Date 01/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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