The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Brachial Plexus Anesthesia Tray.
Device ID | K840287 |
510k Number | K840287 |
Device Name: | BRACHIAL PLEXUS ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | BURRON MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-24 |
Decision Date | 1984-02-23 |