The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Epidural Catheter Tray.
| Device ID | K840201 | 
| 510k Number | K840201 | 
| Device Name: | EPIDURAL CATHETER TRAY | 
| Classification | Eia, Blastomyces Dermatitidis | 
| Applicant | ARIES MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | MJL | 
| CFR Regulation Number | 866.3060 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-01-19 | 
| Decision Date | 1984-03-02 |