510(k) K810257
- Device
- Vessel Tips, Sizes 13-18
- Applicant
- QUINTON, INC.
- 510(k) number
- K810257
- Product code
- FKW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-13
- Date received
- 1981-01-30
- Regulation
- 876.5540
- Classification name
- Tip, Vessel
- 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