BILIARY INDWELLING STENT
FDA 510(k) clearance K834351 · decided 1984-03-22
Clearance details
- K-number
- K834351
- Device name
- BILIARY INDWELLING STENT
- Applicant
- Hobbs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-13
- Decision date
- 1984-03-22
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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