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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name preamplifier, ac-powered, ophthalmic
510(k) Number K921815
Device Name TOMEY PE-300 PORTABLE ERG
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 Number886.1640
Classification Product Code
HLT  
Date Received04/15/1992
Decision Date 07/15/1992
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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