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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K971953
Device Name CONFOSCAN
Applicant
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Applicant Contact DAVE MACLELLAN
Correspondent
Tomey Corporation USA
325 Vassar St. 2nd Floor
Cambridge,  MA  02139
Correspondent Contact DAVE MACLELLAN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received05/28/1997
Decision Date 08/14/1997
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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