Proprietary Name: |
SpeediCath Flex Set; SpeediCath Flex Set with Accessories |
Classification Name: |
CATHETER, STRAIGHT |
Product Code: |
EZD |
Device Class: |
2 |
Regulation Number: |
876.5130 |
Medical Specialty: |
Gastroenterology |
Registered Establishment Name: |
COLOPLAST A/S
|
Registered Establishment Number: |
9610694
|
Premarket Submission Number: |
K222059 |
Owner/Operator: |
Coloplast Corp. |
Owner/Operator Number: |
8010144
|
Establishment Operations: |
Specification Developer
|
|
|