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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, accessories
510(k) Number K053321
Device Name LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
Applicant
XODUS MEDICAL, INC.
702 PROMINENCE DR.
NEW KENSINGTON,  PA  15068
Applicant Contact CRAIG KAFOREY
Correspondent
XODUS MEDICAL, INC.
702 PROMINENCE DR.
NEW KENSINGTON,  PA  15068
Correspondent Contact CRAIG KAFOREY
Regulation Number878.4580
Classification Product Code
FTA  
Date Received11/30/2005
Decision Date 01/19/2006
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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