510(k) K771426
- Device
- Pediatric Infusion T
- Applicant
- QUINTON, INC.
- 510(k) number
- K771426
- Product code
- FKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-12-20
- Date received
- 1977-08-01
- Regulation
- 876.5820
- Classification name
- Connector, Blood Tubing, Infusion T
- 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#
- 2011171
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K891754 | DC-4 SHUNT INFUSION T | Akcess Medical Products, Inc. | 1989-04-07 |