The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Mozaik And Os Moldable Morsels.
| Device ID | K091302 |
| 510k Number | K091302 |
| Device Name: | INTEGRA MOZAIK AND OS MOLDABLE MORSELS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Peter Allan |
| Correspondent | Peter Allan INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2009-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269MSL1501 | K091302 | 000 |
| M269MSL0751 | K091302 | 000 |
| M269MSL0301 | K091302 | 000 |
| M269MSL0151 | K091302 | 000 |
| 10381780071150 | K091302 | 000 |
| 10381780071143 | K091302 | 000 |