Device Classification Name |
Monitor, Esophageal Motility, Anorectal Motility, And Tube
|
510(k) Number |
K032138 |
Device Name |
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER |
Applicant |
MEDTRONIC VASCULAR |
4000 LEXINGTON AVE., NORTH |
SHOREVIEW,
MN
55126 -2893
|
|
Applicant Contact |
DEBORAH KIDDER |
Correspondent |
MEDTRONIC VASCULAR |
4000 LEXINGTON AVE., NORTH |
SHOREVIEW,
MN
55126 -2893
|
|
Correspondent Contact |
DEBORAH KIDDER |
Regulation Number | 876.1725
|
Classification Product Code |
|
Date Received | 07/11/2003 |
Decision Date | 10/09/2003 |
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
|
|
|