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 SQUARE |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JOHN SMITH, MD, JD |
Correspondent |
JETPREP, LTD. |
COLUMBIA SQUARE |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JOHN SMITH, MD, JD |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/06/2012 |
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
|
|
|