FHS — Dialyzer, Single Coil Class II
FDA product code FHS covers "Dialyzer, Single Coil", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- FHS
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K812811 | Erika | MICROCOIL 80 DIALYZER | Dec 3, 1981 |
| K811974 | Erika | MICROCOIL 150 DIALYZER | Sep 16, 1981 |
| K801634 | Bellco Artifidial Organ Spec | THE VITA 2 DISPOSABLE DIALYZER | Dec 17, 1980 |
| K800723 | Erika | MICRO-COIL 100 COIL DIALYZER | May 14, 1980 |
| K800174 | Gambro | GAMBRO LUNDIA COIL DIALYZER | Feb 13, 1980 |
| K790223 | Travenol Laboratories | DIALYZER, CD-800 COIL | Mar 26, 1979 |
| K781102 | Gambro | DIALYZER, DISP., COIL, LUNDIA | Oct 17, 1978 |
| K771349 | Erika | MODIFICATION TO KIDNEY DIALYZER | Aug 2, 1977 |
| K770735 | Travenol Laboratories | DIALYZER, COIL, CD, LSA, 5M1765 | May 10, 1977 |
| K761358 | Bentley Laboratories | COIL DIALYZER MODEL ALT 140 | Jan 10, 1977 |
| K760702 | Erika | ERI-FLO 900 DIALYZER | Nov 19, 1976 |
| K760374 | Erika | DIALYZER (MODEL 1850) | Oct 27, 1976 |