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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 K964312
Device Name MENTOR TONO-PEN 3
Applicant
MENTOR OPHTHALMICS, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Applicant Contact DAVID M DOWNEY
Correspondent
MENTOR OPHTHALMICS, INC.
3000 LONGWATER DR.
NORWELL,  MA  02061 -1672
Correspondent Contact DAVID M DOWNEY
Regulation Number886.1930
Classification Product Code
HKY  
Date Received10/29/1996
Decision Date 11/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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