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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Surgical, Fiberoptic
510(k) Number K080962
Device Name LITE WAND II
Applicant
THOMPSON SURGICAL INSTRUMENTS, INC.
10170 EAST CHERRY BEND ROAD
TRAVERSE CITY,  MI  49684
Applicant Contact STEPHANIE A ZALUCHA
Correspondent
THOMPSON SURGICAL INSTRUMENTS, INC.
10170 EAST CHERRY BEND ROAD
TRAVERSE CITY,  MI  49684
Correspondent Contact STEPHANIE A ZALUCHA
Regulation Number878.4580
Classification Product Code
FST  
Date Received04/04/2008
Decision Date 06/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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