The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Vascular-access-port Withdrawl-blood.
Device ID | K841679 |
510k Number | K841679 |
Device Name: | VASCULAR-ACCESS-PORT WITHDRAWL-BLOOD |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | NORFOLK MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-06-28 |