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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transilluminator, Ac-Powered
510(k) Number K913273
Device Name DROLITE(TM) LIGHT SOURCE
Applicant
Vision Medical, Inc.
820 Optimo Ave.
Fremont,  CA  94539
Applicant Contact JOHNNY L YEE
Correspondent
Vision Medical, Inc.
820 Optimo Ave.
Fremont,  CA  94539
Correspondent Contact JOHNNY L YEE
Regulation Number886.1945
Classification Product Code
HJM  
Date Received07/23/1991
Decision Date 12/04/1991
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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