510(k) K830000
K830000 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "VASCULAR-ACCESS-PORT". The FDA issued a decision of Substantially Equivalent on March 1, 1983. 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
- March 1, 1983
- Date Received
- January 3, 1983
- 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