510(k) K931748
K931748 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTLURION DISP STERI DENTAL/HYGIENE PACK/TRAYS". The FDA issued a decision of Substantially Equivalent (kit) on February 25, 1994. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- February 25, 1994
- Date Received
- April 8, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type