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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prism, Bar, Ophthalmic
510(k) Number K851555
Device Name OPTHALMIC BAR PRISM
Applicant
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Applicant Contact CHAMBORD
Correspondent
Roseburg SA
1054 31st St., NW
Suite 120 Canal Sq.
Washington,  DC  20007
Correspondent Contact CHAMBORD
Regulation Number886.1650
Classification Product Code
HKW  
Date Received04/16/1985
Decision Date 05/23/1985
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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