The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Spinocan Spinal Needle.
Device ID | K820047 |
510k Number | K820047 |
Device Name: | SPINOCAN SPINAL NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-08 |
Decision Date | 1982-01-25 |