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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 K973290
Device Name SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
Applicant
Vaughan Weeks
7346 W. River Rd.
Caledonia,  WI  53108
Applicant Contact VAUGHAN WEEKS
Correspondent
Vaughan Weeks
7346 W. River Rd.
Caledonia,  WI  53108
Correspondent Contact VAUGHAN WEEKS
Regulation Number876.1500
Classification Product Code
MPA  
Date Received09/02/1997
Decision Date 11/14/1997
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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