The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Artimicrobial Removal Device.
Device ID | K830372 |
510k Number | K830372 |
Device Name: | ARTIMICROBIAL REMOVAL DEVICE |
Classification | Device, Antimicrobial Drug Removal |
Applicant | MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LJF |
CFR Regulation Number | 866.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-04 |
Decision Date | 1983-04-08 |