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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti Fog Solution And Accessories, Endoscopy
510(k) Number K063587
Device Name XODUS MEDICAL ANTI-FOG SOLUTION
Applicant
XODUS MEDICAL, INC.
702 PROMINENCE DR.
NEW KENSINGTON,  PA  15068
Applicant Contact BRENDA NIEL
Correspondent
XODUS MEDICAL, INC.
702 PROMINENCE DR.
NEW KENSINGTON,  PA  15068
Correspondent Contact BRENDA NIEL
Regulation Number876.1500
Classification Product Code
OCT  
Date Received12/01/2006
Decision Date 01/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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