The following data is part of a premarket notification filed by Fama Holdings International Corp with the FDA for Hemor-rite Cryotheraphy.
| Device ID | K042564 |
| 510k Number | K042564 |
| Device Name: | HEMOR-RITE CRYOTHERAPHY |
| Classification | Device, Thermal, Hemorrhoids |
| Applicant | FAMA HOLDINGS INTERNATIONAL CORP 6202 NW 88TH AVE. Parkland, FL 33067 |
| Contact | Frank Melendez |
| Correspondent | Frank Melendez FAMA HOLDINGS INTERNATIONAL CORP 6202 NW 88TH AVE. Parkland, FL 33067 |
| Product Code | LKX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-21 |
| Decision Date | 2005-09-30 |
| Summary: | summary |