The following data is part of a premarket notification filed by Etex Corporation with the FDA for Carrigen Pf.
| Device ID | K182107 |
| 510k Number | K182107 |
| Device Name: | CarriGen PF |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX Corporation 38 Sidney Street, 3rd FLoor Cambridge, MA 02139 |
| Contact | Stacy Hutchens |
| Correspondent | Stacy Hutchens ETEX Corporation 38 Sidney Street, 3rd FLoor Cambridge, MA 02139 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2018-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024501232 | K182107 | 000 |
| 00889024501225 | K182107 | 000 |