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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 K961512
Device Name PERKINS HAND-HELD APPLANATION TONOMETER
Applicant
CLEMENT CLARKE, INC.
AIRMED HOUSE, EDINBURGH WAY
HARLOW, ESSEX CM20 2ED
ENGLAND,  GB
Applicant Contact MICHAEL J WILKINSON
Correspondent
CLEMENT CLARKE, INC.
AIRMED HOUSE, EDINBURGH WAY
HARLOW, ESSEX CM20 2ED
ENGLAND,  GB
Correspondent Contact MICHAEL J WILKINSON
Regulation Number886.1930
Classification Product Code
HKY  
Date Received04/19/1996
Decision Date 07/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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