510(k) K854593
K854593 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "NORFOLK MEDICAL PERITONEAL-ACCESS PORT". The FDA issued a decision of Substantially Equivalent on February 4, 1986. The device falls under product code LMQ (Device, Peritoneal Access, Subcutaneous, Implanted), a Class III device. Norfolk Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1986
- Date Received
- November 18, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Peritoneal Access, Subcutaneous, Implanted
- Device Class
- Class III
- Regulation Number
- Review Panel
- HO
- Submission Type