The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Disposable Anoscope/proctoscope.
| Device ID | K080132 |
| 510k Number | K080132 |
| Device Name: | THD DISPOSABLE ANOSCOPE/PROCTOSCOPE |
| Classification | Anoscope And Accessories |
| Applicant | THD SPA VIA CALINDRI 50 S. Lazzaro Di Savena, Bologna, IT 40068 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace THD SPA VIA CALINDRI 50 S. Lazzaro Di Savena, Bologna, IT 40068 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-18 |
| Decision Date | 2008-04-09 |
| Summary: | summary |