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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transilluminator, Battery-Powered
510(k) Number K912747
Device Name LULMITEX NEONATAL TRANSILLUMINATOR
Applicant
Lumitex, Inc.
11941 Abbey Rd., Bldg. H
Cleveland,  OH  44133
Applicant Contact JEFFERY R PARKER
Correspondent
Lumitex, Inc.
11941 Abbey Rd., Bldg. H
Cleveland,  OH  44133
Correspondent Contact JEFFERY R PARKER
Regulation Number886.1945
Classification Product Code
HJN  
Date Received06/21/1991
Decision Date 12/24/1991
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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