510(k) K100365
K100365 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV". The FDA issued a decision of Substantially Equivalent on May 20, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2010
- Date Received
- February 12, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type