510(k) K032975
K032975 is an FDA 510(k) premarket notification submitted by Jms North America Corp. for the device "JMS BLOOD TUBING SETS". The FDA issued a decision of Substantially Equivalent on August 16, 2004. 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. Jms North America Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2004
- Date Received
- September 24, 2003
- 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