The following data is part of a premarket notification filed by Hpk International, Inc. with the FDA for Hpk-a Device Dfor The Treatment Of Hemorrhoids.
| Device ID | K855150 |
| 510k Number | K855150 |
| Device Name: | HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | HPK INTERNATIONAL, INC. 600 NEW HAMPSHIRE AVE, N.W., STE 720 Washington, DC 20037 |
| Contact | Anthony Roccograndi |
| Correspondent | Anthony Roccograndi HPK INTERNATIONAL, INC. 600 NEW HAMPSHIRE AVE, N.W., STE 720 Washington, DC 20037 |
| 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 | 1985-12-26 |
| Decision Date | 1986-04-01 |