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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name refractometer, ophthalmic
510(k) Number K901583
Device Name SHIN NIPPON AUTO REFRACTOMETER QR-007N
Applicant
SODERBERG, INC.
230 EVA ST.
ST. PAUL,  MN  55107
Applicant Contact GORDON H OIE
Correspondent
SODERBERG, INC.
230 EVA ST.
ST. PAUL,  MN  55107
Correspondent Contact GORDON H OIE
Regulation Number886.1760
Classification Product Code
HKO  
Date Received04/04/1990
Decision Date 06/22/1990
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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