The following data is part of a premarket notification filed by Imbiotechnologies with the FDA for Occlusin 500 Artificial Embolization Device.
| Device ID | K093813 |
| 510k Number | K093813 |
| Device Name: | OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | IMBIOTECHNOLOGIES 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson IMBIOTECHNOLOGIES 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-11 |
| Decision Date | 2010-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540270000070 | K093813 | 000 |
| 07540270000063 | K093813 | 000 |
| 07540270000056 | K093813 | 000 |
| 07540270000049 | K093813 | 000 |
| 07540270000032 | K093813 | 000 |
| 07540270000025 | K093813 | 000 |
| 07540270000018 | K093813 | 000 |