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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic irrigation/suction system
510(k) Number K122740
Model OL-103037, OL-133037, OL-168037, PE-105038, PE-150038, PE-170038, FU-169038, OL-168032,
Device Name JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN
Original Applicant
JETPREP, LTD.
columbia square
555 13th street, nw
washington,  DC  20004
Original Contact john smith, md, jd
Regulation Number876.1500
Classification Product Code
OCX  
Date Received09/06/2012
Decision Date 12/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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