510(k) K920697
- Device
- DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP
- Applicant
- NATIONAL MEDICAL CARE, MEDICAL PRODUCTS DIV., INC.
- 510(k) number
- K920697
- Product code
- FJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-09-21
- Date received
- 1992-02-14
- Regulation
- 876.5830
- Classification name
- Dialyzer, Disposable
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT BISHOP
- Address
- Two Volvo Dr. Rockleigh NJ US 07647 07647
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FJH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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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