FJH — Dialyzer, Disposable Class II
FDA product code FJH covers "Dialyzer, Disposable", a Class II medical device regulated under 21 CFR 876.5830. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FJH
- Device Class
- Class II
- Regulation Number
- 876.5830
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K920697 | national medical care, medical products div | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | September 21, 1992 |
| K861646 | societe d' analyses bio-pharmaceutiques | BIO-CARB D16000, D16001, AND D17000 | August 7, 1986 |
| K852764 | trans-national trade development | IDECAP DIALYZER | September 20, 1985 |
| K822395 | travenol laboratories | CF 1211 CAPILLARY FLOW DIALYZER CODE | August 12, 1982 |