The following data is part of a premarket notification filed by Sciences Et Bio Materiaux (sbm) with the FDA for Biosorb Resorbable Void Filler.
| Device ID | K021963 |
| 510k Number | K021963 |
| Device Name: | BIOSORB RESORBABLE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | SCIENCES ET BIO MATERIAUX (SBM) ZI DU MONGE Lordes, FR F 65100 |
| Contact | Denis Clement |
| Correspondent | Denis Clement SCIENCES ET BIO MATERIAUX (SBM) ZI DU MONGE Lordes, FR F 65100 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-14 |
| Decision Date | 2003-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154007009 | K021963 | 000 |
| 03760154000192 | K021963 | 000 |
| 03760154000208 | K021963 | 000 |
| 03760154000215 | K021963 | 000 |
| 03760154000246 | K021963 | 000 |
| 03760154000253 | K021963 | 000 |
| 03760154000277 | K021963 | 000 |
| 03760154000291 | K021963 | 000 |
| 03760154000307 | K021963 | 000 |
| 03760154000161 | K021963 | 000 |
| 03760154000154 | K021963 | 000 |
| 03760154000734 | K021963 | 000 |
| 03760154000031 | K021963 | 000 |
| 03760154000048 | K021963 | 000 |
| 03760154000062 | K021963 | 000 |
| 03760154000079 | K021963 | 000 |
| 03760154000086 | K021963 | 000 |
| 03760154000130 | K021963 | 000 |
| 03760154000147 | K021963 | 000 |
| 03760154000321 | K021963 | 000 |
| 03760154000352 | K021963 | 000 |
| 03760154004275 | K021963 | 000 |
| 03760154004282 | K021963 | 000 |
| 03760154004633 | K021963 | 000 |
| 03760154004640 | K021963 | 000 |
| 03760154004671 | K021963 | 000 |
| 03760154004688 | K021963 | 000 |
| 03760154004824 | K021963 | 000 |
| 03760154004831 | K021963 | 000 |
| 03760154004237 | K021963 | 000 |
| 03760154004220 | K021963 | 000 |
| 03760154000376 | K021963 | 000 |
| 03760154000390 | K021963 | 000 |
| 03760154000406 | K021963 | 000 |
| 03760154000420 | K021963 | 000 |
| 03760154000451 | K021963 | 000 |
| 03760154000475 | K021963 | 000 |
| 03760154000666 | K021963 | 000 |
| 03760154000697 | K021963 | 000 |
| 03760154000680 | K021963 | 000 |