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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 K083710
Device Name RETRACTOR LITE
Applicant
THOMAS SURGICAL INSTRUMENTS, INC.
10170 E. CHERRY BEND RD.
TRAVERSE CITY,  MI  49684
Applicant Contact STEPHANIE A ZALUCHA
Correspondent
THOMAS 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 Received12/15/2008
Decision Date 02/23/2009
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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