The following data is part of a premarket notification filed by Science For Biomaterials with the FDA for Modification To: Biosorb Resorbable Void Filler.
| Device ID | K071155 |
| 510k Number | K071155 |
| Device Name: | MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER |
| 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 | 2007-04-25 |
| Decision Date | 2007-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154001656 | K071155 | 000 |
| 03760154002080 | K071155 | 000 |
| 03760154002073 | K071155 | 000 |
| 03760154002066 | K071155 | 000 |
| 03760154002059 | K071155 | 000 |
| 03760154001540 | K071155 | 000 |
| 03760154001533 | K071155 | 000 |
| 03760154001526 | K071155 | 000 |
| 03760154001519 | K071155 | 000 |
| 03760154001502 | K071155 | 000 |
| 03760154001489 | K071155 | 000 |
| 03760154001472 | K071155 | 000 |
| 03760154002097 | K071155 | 000 |
| 03760154002103 | K071155 | 000 |
| 03760154002110 | K071155 | 000 |
| 03760154001649 | K071155 | 000 |
| 03760154001632 | K071155 | 000 |
| 03760154001625 | K071155 | 000 |
| 03760154001618 | K071155 | 000 |
| 03760154001601 | K071155 | 000 |
| 03760154002196 | K071155 | 000 |
| 03760154002189 | K071155 | 000 |
| 03760154002172 | K071155 | 000 |
| 03760154002165 | K071155 | 000 |
| 03760154002141 | K071155 | 000 |
| 03760154002134 | K071155 | 000 |
| 03760154001496 | K071155 | 000 |