Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
FDA 510(k) clearance K180868 · decided 2018-07-06
Clearance details
- K-number
- K180868
- Device name
- Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
- Applicant
- Cook Ireland
- Decision
- Substantially Equivalent
- Date received
- 2018-04-03
- Decision date
- 2018-07-06
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Limerick, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.