510(k) K792174
- Device
- MODEL DM 353 & DM-353-L SINGLE NEEDLE
- Applicant
- EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
- 510(k) number
- K792174
- Product code
- FIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-11-16
- Date received
- 1979-10-29
- Regulation
- 876.5820
- Classification name
- Set, Dialysis, Single Needle With Uni-directional Pump
- 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 FIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K873279 | 8810 PUMP-PUMP SINGLE NEEDLE DEVICE | Cd Medical, Inc. | 1987-10-23 |
| K820173 | COBE SINGLE-NEEDLE CONTROLLER #18-756 | Cobe Laboratories, Inc. | 1982-03-23 |
| K802230 | BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP | Cardio Med Supplies, Inc. | 1980-12-22 |
| K801967 | MEDCOMP FEMORAL VEIN CATHETER | Medical Components, Inc. | 1980-09-26 |
| K772147 | GW 35 GUIDE WIRE | Sorensen Research | 1977-11-28 |
Legacy Summary#
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FDA Review#
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