Proprietary Name: |
Self-Cath Closed System |
Classification Name: |
TRAY, CATHETERIZATION, STERILE URETHRAL, WITH OR WITHOUT CATHETER (KIT) |
Product Code: |
FCM |
Device Class: |
2 |
Regulation Number: |
876.5130 |
Medical Specialty: |
Gastroenterology |
Registered Establishment Name: |
COLOPLAST A/S
|
Registered Establishment Number: |
9610694
|
Premarket Submission Number: |
K223821 |
Owner/Operator: |
Coloplast Corp. |
Owner/Operator Number: |
8010144
|
Establishment Operations: |
Specification Developer
|
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