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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 K924760
Device Name TOMEY PROTON TONOMETER
Applicant
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Applicant Contact LORI A TRUITT
Correspondent
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Correspondent Contact LORI A TRUITT
Regulation Number886.1930
Classification Product Code
HKY  
Date Received09/23/1992
Decision Date 04/05/1993
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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