The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Espocan Combined Spinal/epidural Needle Set & Tray.
Device ID | K932400 |
510k Number | K932400 |
Device Name: | ESPOCAN COMBINED SPINAL/EPIDURAL NEEDLE SET & TRAY |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
Contact | Christine M Harris |
Correspondent | Christine M Harris B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-18 |
Decision Date | 1993-12-13 |