The following data is part of a premarket notification filed by Thd Spa with the FDA for Family Of Thd Disposable Anoscopes/proctoscopes/rectoscopes.
| Device ID | K091490 |
| 510k Number | K091490 |
| Device Name: | FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES |
| Classification | Anoscope And Accessories |
| 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 | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-20 |
| Decision Date | 2009-06-11 |
| Summary: | summary |