510(k) K761358
- Device
- COIL DIALYZER MODEL ALT 140
- Applicant
- Bentley Laboratories, Inc.
- 510(k) number
- K761358
- Product code
- FHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-10
- Date received
- 1976-12-29
- Regulation
- 876.5820
- Classification name
- Dialyzer, Single Coil
- 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 FHS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812811 | MICROCOIL 80 DIALYZER | Erika, Inc. | 1981-12-03 |
| K811974 | MICROCOIL 150 DIALYZER | Erika, Inc. | 1981-09-16 |
| K801634 | THE VITA 2 DISPOSABLE DIALYZER | Bellco Artifidial Organ Spec., Inc. | 1980-12-17 |
| K800723 | MICRO-COIL 100 COIL DIALYZER | Erika, Inc. | 1980-05-14 |
| K800174 | GAMBRO LUNDIA COIL DIALYZER | Gambro, Inc. | 1980-02-13 |
| K790223 | DIALYZER, CD-800 COIL | Travenol Laboratories, S.A. | 1979-03-26 |
| K781102 | DIALYZER, DISP., COIL, LUNDIA | Gambro, Inc. | 1978-10-17 |
| K771349 | MODIFICATION TO KIDNEY DIALYZER | Erika, Inc. | 1977-08-02 |
| K770735 | DIALYZER, COIL, CD, LSA, 5M1765 | Travenol Laboratories, S.A. | 1977-05-10 |
| K760702 | ERI-FLO 900 DIALYZER | Erika, Inc. | 1976-11-19 |
| K760374 | DIALYZER (MODEL 1850) | Erika, Inc. | 1976-10-27 |