510(k) K060352
K060352 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS". The FDA issued a decision of Substantially Equivalent on May 31, 2006. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Health Line International Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2006
- Date Received
- February 13, 2006
- 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