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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, battery-powered
510(k) Number K873987
Device Name IRAS GLARE TESTER
Applicant
RANDWAL INSTRUMENT CO., INC.
278 WORCESTER ST.
SOUTHBRIDGE,  MA  01550
Applicant Contact CYR
Correspondent
RANDWAL INSTRUMENT CO., INC.
278 WORCESTER ST.
SOUTHBRIDGE,  MA  01550
Correspondent Contact CYR
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received09/29/1987
Decision Date 11/24/1987
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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