FKL — Insert, Pump, Blood Class II
FDA product code FKL covers "Insert, Pump, Blood", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FKL
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K854084 | organon teknika | PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT | November 8, 1985 |