510(k) K760781
- Device
- TRIEX-1 HOLLOW FIBER DIALYZER
- Applicant
- Extracorporeal Medical Specialities, Inc.
- 510(k) number
- K760781
- Product code
- FJT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-06
- Date received
- 1976-10-05
- Regulation
- 876.5820
- Classification name
- Intracatheter, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863297 | MODIFICATION'S TO TORAY'S B-2 SERIES | National Medical Care, Medical Products Div., Inc. | 1986-09-25 |
| K772146 | CATHETER, VEIN, FEMORAL, SF 10 | Sorensen Research | 1977-11-29 |
| K772148 | CATHETER, FEMORAL VEIN, SF 6 | Sorensen Research | 1977-11-29 |
| K770047 | DNC 151 VINCA-FLO | Sorensen Research | 1977-01-14 |