Device Classification Name |
Insufflator, Automatic Carbon-Dioxide For Endoscope
|
510(k) Number |
K090879 |
Device Name |
INSUFLOW CO2IONSHIELD |
Applicant |
LEXION MEDICAL, LLC. |
5000 TOWNSHIP PKWY |
ST. PAUL,
MN
55110
|
|
Applicant Contact |
BERNARD HORWATH |
Correspondent |
LEXION MEDICAL, LLC. |
5000 TOWNSHIP PKWY |
ST. PAUL,
MN
55110
|
|
Correspondent Contact |
BERNARD HORWATH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/31/2009 |
Decision Date | 07/23/2009 |
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
|
|
|