The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Sure Flow Tubing.
Device ID | K800664 |
510k Number | K800664 |
Device Name: | SURE FLOW TUBING |
Classification | Tubing, Pressure And Accessories |
Applicant | B & F MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYX |
CFR Regulation Number | 868.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-26 |
Decision Date | 1980-04-02 |