The following data is part of a premarket notification filed by Healthcare Suppliers, Inc. with the FDA for Haemotronic Blood Line Set.
Device ID | K896407 |
510k Number | K896407 |
Device Name: | HAEMOTRONIC BLOOD LINE SET |
Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
Applicant | HEALTHCARE SUPPLIERS, INC. 3925 W. NORTHSIDE DR. Jackson, MS 39209 |
Contact | John O Williams |
Correspondent | John O Williams HEALTHCARE SUPPLIERS, INC. 3925 W. NORTHSIDE DR. Jackson, MS 39209 |
Product Code | FJK |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-07 |
Decision Date | 1990-04-25 |