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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perimeter, Automatic, Ac-Powered
510(k) Number K832555
Device Name OCUMAP 100 AUTOPERIMETER
Applicant
Shorashim
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Shorashim
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number886.1605
Classification Product Code
HPT  
Date Received08/01/1983
Decision Date 02/10/1984
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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