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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
Device Name JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN
Applicant
Jetprep, Ltd.
Columbia Sq.
555 13th St. NW
Washington,  DC  20004
Applicant Contact JOHN SMITH, MD, JD
Correspondent
Jetprep, Ltd.
Columbia Sq.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JOHN SMITH, MD, JD
Regulation Number876.1500
Classification Product Code
OCX  
Date Received09/06/2012
Decision Date 12/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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