510(k) K760725
- Device
- Coil Machine Adapter
- Applicant
- GAMBRO, INC.
- 510(k) number
- K760725
- Product code
- FLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-27
- Date received
- 1976-09-27
- Regulation
- 876.5820
- Classification name
- Station, Dialysis Control, Negative Pressure Type
- 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