Proprietary Name: |
Orchestra® Hydrophilic guidewire |
Classification Name: |
ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY |
Product Code: |
OCY |
Device Class: |
2 |
Regulation Number: |
876.1500 |
Medical Specialty: |
Gastroenterology |
Registered Establishment Name: |
COLOPLAST MANUFACTURING FRANCE, SAS
|
Registered Establishment Number: |
9610711
|
Premarket Submission Number: |
K150927 |
Owner/Operator: |
Coloplast Corp. |
Owner/Operator Number: |
8010144
|
Establishment Operations: |
Specification Developer
|