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 |