The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Port, Nmi Port Ii.
Device ID | K153228 |
510k Number | K153228 |
Device Name: | NMI Port, NMI Port II |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
Contact | Robin Fuller |
Correspondent | Robin Fuller NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-06 |
Decision Date | 2015-12-04 |
Summary: | summary |