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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photostimulator, Ac-Powered
510(k) Number K873990
Device Name IRAS EDS INTERFEROMETRIC STIMULATOR
Applicant
Randwal Instrument Co., Inc.
278 Worcester St.
Southbridge,  MA  01550
Applicant Contact ROBERT ST.CYR
Correspondent
Randwal Instrument Co., Inc.
278 Worcester St.
Southbridge,  MA  01550
Correspondent Contact ROBERT ST.CYR
Regulation Number886.1630
Classification Product Code
HLX  
Date Received10/01/1987
Decision Date 02/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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