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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 K864012
Device Name IRAS PERIMETER
Applicant
RANDWAL INSTRUMENT CO., INC.
278 WORCESTER ST.
SOUTHBRIDGE,  MA  01550
Applicant Contact REMIJAN, PH.D.
Correspondent
RANDWAL INSTRUMENT CO., INC.
278 WORCESTER ST.
SOUTHBRIDGE,  MA  01550
Correspondent Contact REMIJAN, PH.D.
Regulation Number886.1360
Classification Product Code
HPJ  
Date Received10/15/1986
Decision Date 12/12/1986
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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