510(k) K954181
K954181 is an FDA 510(k) premarket notification submitted by Canyon Medical Products for the device "CANYONS BI-DIRECTIONAL CHECK VALVE". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Canyon Medical Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1995
- Date Received
- September 6, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dispenser, Liquid Medication
- Device Class
- Class I
- Regulation Number
- 880.6430
- Review Panel
- HO
- Submission Type