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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prism, Gonioscopic
510(k) Number K861027
Device Name KETA HAND-HELD TONOMETER
Applicant
Keta Corp.
9 Canal St.
Danvers,  MA  01923
Applicant Contact KENNETH TAYLOR
Correspondent
Keta Corp.
9 Canal St.
Danvers,  MA  01923
Correspondent Contact KENNETH TAYLOR
Regulation Number886.1660
Classification Product Code
HKS  
Date Received03/18/1986
Decision Date 05/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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