510(k) K822395
- Device
- CF 1211 CAPILLARY FLOW DIALYZER CODE
- Applicant
- TRAVENOL LABORATORIES, S.A.
- 510(k) number
- K822395
- Product code
- FJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-08-12
- Date received
- 1982-08-11
- 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#
- 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 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 |
| K861646 | BIO-CARB D16000, D16001, AND D17000 | Societe D' Analyses Bio-Pharmaceutiques,Inc. | 1986-08-07 |
| K852764 | IDECAP DIALYZER | Trans-National Trade Development Corp. | 1985-09-20 |
Legacy Summary#
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FDA Review#
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