The following data is part of a premarket notification filed by Etex Corporation with the FDA for Carricell.
| Device ID | K132868 |
| 510k Number | K132868 |
| Device Name: | CARRICELL |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX CORPORATION 675 MASSACHUSETTS AVE Cambridge, MA 02139 |
| Contact | Michael Strunk, Phd. |
| Correspondent | Michael Strunk, Phd. ETEX CORPORATION 675 MASSACHUSETTS AVE Cambridge, MA 02139 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-13 |
| Decision Date | 2015-02-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CARRICELL 77481597 4115188 Dead/Cancelled |
LIFE SCIENCE ENTERPRISES, INC. 2008-05-22 |