510(k) K771426
K771426 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "PEDIATRIC INFUSION T". The FDA issued a decision of Substantially Equivalent on December 20, 1977. The device falls under product code FKB (Connector, Blood Tubing, Infusion T), a Class II device regulated under 21 CFR 876.5820. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 1977
- Date Received
- August 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Blood Tubing, Infusion T
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type