CARRIGEN
Filler, Bone Void, Calcium Compound
ETEX CORP.
The following data is part of a premarket notification filed by Etex Corp. with the FDA for Carrigen.
Pre-market Notification Details
| Device ID | K093447 |
| 510k Number | K093447 |
| Device Name: | CARRIGEN |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. 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 | 2009-11-05 |
| Decision Date | 2010-02-18 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024430075 | K093447 | 000 |
| 00889024406544 | K093447 | 000 |
| 00889024406537 | K093447 | 000 |
Trademark Results [CARRIGEN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARRIGEN 77413982 3974883 Live/Registered |
Etex Corporation 2008-03-05 |
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