510(k) K833139
- Device
- Acute Hemodialysis Trays
- Applicant
- INTERMED, INC.
- 510(k) number
- K833139
- Product code
- KNZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-12-22
- Date received
- 1983-09-14
- Regulation
- 876.5540
- Classification name
- Accessories, A-V Shunt
- 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
FDA Registration Numbers#
- 1319639
- 2518902
- 3003915875
- 1282497
- 3030574705
- 2030624
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KNZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842039 | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | Argon Medical Corp. | 1985-01-29 |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Packaging Technologies, Inc. | 1984-12-17 |
| K842864 | VACCESS FEMORAL CANNULA | Vas-Cath of Canada , Ltd. | 1984-08-08 |
| K842416 | DUO FLOW CATHETER-MC 54 | Medical Components, Inc. | 1984-07-26 |
| K841530 | DOUBLE LUMEN SUBLCAVIAN-FEMORAL | Medical Components, Inc. | 1984-06-25 |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | Top Surgical Manufacturers Co. | 1984-04-20 |
| K840424 | HEMOCATH REPAIR KIT | Quinton, Inc. | 1984-03-05 |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | Renal Systems, Inc. | 1984-02-21 |
| K834510 | RENAFLO AVF SET FOR HEMODIALYSIS | Renal Systems, Inc. | 1984-02-04 |