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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 S.W. 117TH AVE.,SUITE 103
MIAMI,  FL  33183 -3816
Applicant Contact ANDRES R QUIROZ
Correspondent
GOLDEN VISION, INC.
7436 S.W. 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
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