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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K963417
Device Name VITLITE (TR7700)
Applicant
Escalon Trek Medical
822 Swan Dr.
Mukwonago,  WI  53149
Applicant Contact RONALD L HUENEKE
Correspondent
Escalon Trek Medical
822 Swan Dr.
Mukwonago,  WI  53149
Correspondent Contact RONALD L HUENEKE
Regulation Number876.1500
Classification Product Code
MPA  
Date Received08/30/1996
Decision Date 12/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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