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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 K182491
Device Name Applanation tonometer AT-2
Applicant
Takagi Seiko Co., Ltd.
330-2
Nakano-Shi,  JP 383-8585
Applicant Contact Shinya Kitamura
Correspondent
Takagi Seiko Co., Ltd.
330-2
Nakano-Shi,  JP 383-8585
Correspondent Contact Shinya Kitamura
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/11/2018
Decision Date 12/10/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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