JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038


Device Classification Name

endoscopic irrigation/suction system

510(k) Number K111274
Device Name JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
Applicant
JETPREP, LTD.
columbia square
555 13th street, nw
washington, 
DC 
20004

Applicant Contact john smith
Correspondent
JETPREP, LTD.
columbia square
555 13th street, nw
washington, 
DC 
20004

Correspodent Contact john smith
Regulation Number 876.1500
Classification Product Code
OCX  
Date Received 05/05/2011
Decision Date 04/04/2012
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