The following data is part of a premarket notification filed by Smith & Nephew, Mpl Division with the FDA for Micro Z Dispos. Spinal Anesth. Needle.
Device ID | K832126 |
510k Number | K832126 |
Device Name: | MICRO Z DISPOS. SPINAL ANESTH. NEEDLE |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | SMITH & NEPHEW, MPL DIVISION 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 | 1983-07-01 |
Decision Date | 1983-08-12 |