The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Bandy.
| Device ID | K093497 |
| 510k Number | K093497 |
| Device Name: | THD BANDY |
| Classification | Ligator, Hemorrhoidal |
| Applicant | THD SPA VIA BORGO SANTA CRISTINA 12 Imola, Bo, IT 40026 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace THD SPA VIA BORGO SANTA CRISTINA 12 Imola, Bo, IT 40026 |
| Product Code | FHN |
| CFR Regulation Number | 876.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-12 |
| Decision Date | 2010-07-15 |