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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K111495
Device Name COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
Original Applicant
WILSON-COOK MEDICAL INC.
4900 bethania station rd
winston-salem,  NC  27105
Original Contact marge walls-walker
Regulation Number876.1500
Classification Product Code
FBK  
Date Received05/31/2011
Decision Date 07/19/2011
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
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