The following data is part of a premarket notification filed by Norfolk Medical Products, Inc. with the FDA for Vascular-access-port.
Device ID | K830000 |
510k Number | K830000 |
Device Name: | VASCULAR-ACCESS-PORT |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | NORFOLK MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-03 |
Decision Date | 1983-03-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VASCULAR-ACCESS-PORT 73368754 not registered Dead/Abandoned |
NORFOLK MEDICAL PRODUCTS, INC. 1982-06-09 |