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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Visual Field, Laser
510(k) Number K853556
Device Name LASER IRAS
Applicant
Randwal Instrument Co., Inc.
278 Worcester St.
Southbridge,  MA  01550
Applicant Contact JAMES R SCHUBERT
Correspondent
Randwal Instrument Co., Inc.
278 Worcester St.
Southbridge,  MA  01550
Correspondent Contact JAMES R SCHUBERT
Regulation Number886.1360
Classification Product Code
HPJ  
Date Received08/26/1985
Decision Date 11/01/1985
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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