510(k) K841679
K841679 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD". The FDA issued a decision of Substantially Equivalent on Jun 28, 1984. 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 19 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 28, 1984
- Date Received
- Apr 23, 1984
- 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
- 510(k)