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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 K090217
Device Name BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
Applicant
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS,  MN  55411
Applicant Contact SURESH GHAL
Correspondent
COLOPLAST A/S
1601 WEST RIVER ROAD N
MINNEAPOLIS,  MN  55411
Correspondent Contact SURESH GHAL
Regulation Number876.1500
Classification Product Code
FBK  
Date Received01/29/2009
Decision Date 04/23/2009
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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