The following data is part of a premarket notification filed by Dunmore Corp. with the FDA for Device For The Treatment Of Hemorrhoids.
| Device ID | K822649 |
| 510k Number | K822649 |
| Device Name: | DEVICE FOR THE TREATMENT OF HEMORRHOIDS |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | DUNMORE CORP. 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 | 1982-09-01 |
| Decision Date | 1982-11-03 |