510(k) K884243
K884243 is an FDA 510(k) premarket notification submitted by Mediflex Intl. for the device "BLOOD TUBING SET". The FDA issued a decision of Substantially Equivalent on December 8, 1988. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Mediflex Intl. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1988
- Date Received
- October 11, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type