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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 K964555
Device Name VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
Applicant
Vitrotec, Inc.
15 Foxhunt Dr.
Chesterfield,  MO  63017
Applicant Contact JAMES TAYLOR
Correspondent
Vitrotec, Inc.
15 Foxhunt Dr.
Chesterfield,  MO  63017
Correspondent Contact JAMES TAYLOR
Regulation Number876.1500
Classification Product Code
MPA  
Date Received11/13/1996
Decision Date 03/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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