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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 E Cherry Bend Rd.
Traverse City,  MI  49684
Applicant Contact STEPHANIE A ZALUCHA
Correspondent
Thompson Surgical Instruments, Inc.
10170 E Cherry Bend Rd.
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
Predetermined Change
Control Plan Authorized		 No
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