510(k) K861646
- Device
- Bio-carb D16000, D16001, And D17000
- Applicant
- SOCIETE D' ANALYSES BIO-PHARMACEUTIQUES,INC.
- 510(k) number
- K861646
- Product code
- FJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-08-07
- Date received
- 1986-04-30
- Regulation
- 876.5830
- Classification name
- Dialyzer, Disposable
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HAMER ASSOC.
- Address
- P.O. Box 16598 Wedgwood Station Fort Worth TX US 76162 76162
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920697 | DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP | National Medical Care, Medical Products Div., Inc. | 1992-09-21 |
| K852764 | IDECAP DIALYZER | Trans-National Trade Development Corp. | 1985-09-20 |
| K822395 | CF 1211 CAPILLARY FLOW DIALYZER CODE | Travenol Laboratories, S.A. | 1982-08-12 |