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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 K203850
Device Name CATS®-D Tonometer Prism
Applicant
CATS Tonometer LLC
1517 N. Wilmot
Suite 143
Tucson,  AZ  85712
Applicant Contact Nannon Roosa
Correspondent
CATS Tonometer LLC
1517 N. Wilmot
Suite 143
Tucson,  AZ  85712
Correspondent Contact Paul Kramsky
Regulation Number886.1930
Classification Product Code
HKY  
Date Received12/31/2020
Decision Date 06/14/2021
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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