The following data is part of a premarket notification filed by Angiologica B. M. Srl with the FDA for Hemorpex System.
| Device ID | K090432 |
| 510k Number | K090432 |
| Device Name: | HEMORPEX SYSTEM |
| Classification | Anoscope And Accessories |
| Applicant | ANGIOLOGICA B. M. SRL 4, VIA GIOVANNI XXIII San Martino Siccomario, Pavia, IT 27028 |
| Contact | Roberto Manco |
| Correspondent | Roberto Manco ANGIOLOGICA B. M. SRL 4, VIA GIOVANNI XXIII San Martino Siccomario, Pavia, IT 27028 |
| Product Code | FER |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-19 |
| Decision Date | 2009-05-29 |
| Summary: | summary |