510(k) K854346
K854346 is an FDA 510(k) premarket notification submitted by Mediflex Intl. for the device "MEDIFLEX DISPOSABLE TUBING CLAMP". The FDA issued a decision of Substantially Equivalent on November 18, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Mediflex Intl. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1985
- Date Received
- October 29, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type