The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Antimicrobial Removal Device.
| Device ID | K810613 |
| 510k Number | K810613 |
| Device Name: | ANTIMICROBIAL REMOVAL DEVICE |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | MARION LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LKX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-06 |
| Decision Date | 1981-04-03 |