510(k) K852764
- Device
- IDECAP DIALYZER
- Applicant
- TRANS-NATIONAL TRADE DEVELOPMENT CORP.
- 510(k) number
- K852764
- Product code
- FJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-20
- Date received
- 1985-06-28
- 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
- ROBERT KELLER
- Address
- 2 Dag Hammarskjold Plz. 866 Second Ave. New York NY US 10017 10017
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 |
| K822395 | CF 1211 CAPILLARY FLOW DIALYZER CODE | Travenol Laboratories, S.A. | 1982-08-12 |
Legacy Summary#
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FDA Review#
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