510(k) K872364
- Device
- HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
- Applicant
- TRAVENOL LABORATORIES, S.A.
- 510(k) number
- K872364
- Product code
- FII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-13
- Date received
- 1987-06-18
- Regulation
- 876.5860
- Classification name
- System, Dialysate Delivery, Sealed
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT L WILKINSON
- Address
- Wilson Rd. At Rte. 120 P.O. Box 490 Round Lake IL US 60073 60073
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FII #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030470 | NXSTAGE SYSTEM ONE | Nxstage Medical, Inc. | 2003-07-07 |
| K881270 | GAMBRO MULTIPURPOSE SYSTEM MPS-10 | Gambro, Inc. | 1988-08-24 |
| K862716 | HEMOFILTRATION SYSTEM 10 | Gambro, Inc. | 1986-09-09 |
| K822386 | COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA | Hospal Medical Corp. | 1982-10-06 |
Legacy Summary#
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FDA Review#
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