510(k) K771425
- Device
- A-v Shunt Extension
- Applicant
- QUINTON, INC.
- 510(k) number
- K771425
- Product code
- FKN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-01-03
- Date received
- 1977-08-01
- Regulation
- 876.5540
- Classification name
- Adaptor, 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
Source Documents#
510(k) summary PDF not indicated by FDA