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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Corneal
510(k) Number K961805
Device Name TOMEY DTL ELECTRODE
Applicant
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Applicant Contact SUSUMU NOZAWA
Correspondent
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Correspondent Contact SUSUMU NOZAWA
Regulation Number886.1220
Classification Product Code
HLZ  
Date Received05/10/1996
Decision Date 05/09/1997
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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