The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd N-ano Anoscope.
| Device ID | K133687 |
| 510k Number | K133687 |
| Device Name: | THD N-ANO ANOSCOPE |
| Classification | Anoscope And Accessories |
| Applicant | THD SPA VIA A.ALTOBELLI BONETTI, 3/A Imola, Bo, IT 40026 |
| Contact | Guido Bonapace |
| Correspondent | Guido Bonapace THD SPA VIA A.ALTOBELLI BONETTI, 3/A 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 | 2013-12-02 |
| Decision Date | 2013-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033737710723 | K133687 | 000 |
| 28033737710719 | K133687 | 000 |
| 28033737710702 | K133687 | 000 |
| 18033737710699 | K133687 | 000 |