The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Bio 1-kit Biosorb Filled Cartridge.
| Device ID | K061022 |
| 510k Number | K061022 |
| Device Name: | BIO 1-KIT BIOSORB FILLED CARTRIDGE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCE FOR BIOMATERIALS ZI DU MONGE Lourdes, FR 65100 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-13 |
| Decision Date | 2006-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154004978 | K061022 | 000 |
| 03760154004848 | K061022 | 000 |
| 03760154004855 | K061022 | 000 |
| 03760154004862 | K061022 | 000 |
| 03760154004879 | K061022 | 000 |
| 03760154004886 | K061022 | 000 |
| 03760154004893 | K061022 | 000 |
| 03760154004909 | K061022 | 000 |
| 03760154004916 | K061022 | 000 |
| 03760154004923 | K061022 | 000 |
| 03760154004930 | K061022 | 000 |
| 03760154004947 | K061022 | 000 |
| 03760154004954 | K061022 | 000 |
| 03760154004961 | K061022 | 000 |
| 03760154004817 | K061022 | 000 |