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 |