510(k) K822386
- Device
- COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA
- Applicant
- HOSPAL MEDICAL CORP.
- 510(k) number
- K822386
- Product code
- FII
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-10-06
- Date received
- 1982-08-09
- 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#
- 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 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 |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Travenol Laboratories, S.A. | 1987-10-13 |
| K862716 | HEMOFILTRATION SYSTEM 10 | Gambro, Inc. | 1986-09-09 |
Legacy Summary#
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FDA Review#
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