The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Antimicrobial Removal Device (ard).
Device ID | K822344 |
510k Number | K822344 |
Device Name: | ANTIMICROBIAL REMOVAL DEVICE (ARD) |
Classification | Device, Antimicrobial Drug Removal |
Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LJF |
CFR Regulation Number | 866.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-05 |
Decision Date | 1982-08-25 |