The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Continuous Epidural Anesthes. Tray.
Device ID | K840179 |
510k Number | K840179 |
Device Name: | CONTINUOUS EPIDURAL ANESTHES. TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-17 |
Decision Date | 1984-02-24 |