510(k) K870519

SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT by Norfolk Medical Products, Inc. — Product Code LJT

K870519 is an FDA 510(k) premarket notification submitted by Norfolk Medical Products, Inc. for the device "SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY DEPOT". The FDA issued a decision of Substantially Equivalent on April 15, 1987. 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
April 15, 1987
Date Received
February 6, 1987
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