Proprietary Name: |
Peristeen Irrigation Accessory Unit; Peristeen Irrigation Rectal Catheter; Peristeen Irrigation TubePeristeen Irrigation Tube; Peristeen Plus balloon catheter; Peristeen Plus Transanal Irrigation System; Peristeen Plus tube; Peristeen System Strap; Peristeen Transanal Irrigation System; Peristeen™ Anal Irrigation System |
Classification Name: |
ENEMA KIT |
Product Code: |
FCE |
Device Class: |
1 |
Regulation Number: |
876.5210 |
Medical Specialty: |
Gastroenterology |
Registered Establishment Name: |
COLOPLAST A/S
|
Registered Establishment Number: |
9610694
|
Premarket Submission Number: |
K140310 |
Owner/Operator: |
Coloplast Corp. |
Owner/Operator Number: |
8010144
|
Establishment Operations: |
Specification Developer
|