510(k) K112713
K112713 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS". The FDA issued a decision of Substantially Equivalent on October 27, 2011. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2011
- Date Received
- September 19, 2011
- Clearance Type
- Special
- 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