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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 K173904
Device Name CATS Tonometer Prism
Applicant
Cats Tonometer, LLC
1517 N. Wilmot
Suite 143
Tucson,  AZ  85712
Applicant Contact Sean J. McCafferty
Correspondent
Rockin' Regulatory, Inc.
21831 Tumbleweed Cir.
Lake Forest,  CA  92630
Correspondent Contact Paul Kramsky
Regulation Number886.1930
Classification Product Code
HKY  
Date Received12/22/2017
Decision Date 03/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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