510(k) K770047
K770047 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "DNC 151 VINCA-FLO". The FDA issued a decision of Substantially Equivalent on January 14, 1977. The device falls under product code FJT (Intracatheter, Dialysis), a Class II device regulated under 21 CFR 876.5820. Sorensen Research has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 1977
- Date Received
- January 10, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intracatheter, Dialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type