The following data is part of a premarket notification filed by Etex Corp. with the FDA for Gamma-bsm, Beta-bsm, Equivabone, Carigen.
| Device ID | K101557 |
| 510k Number | K101557 |
| Device Name: | GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN |
| 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 | 2010-06-04 |
| Decision Date | 2010-07-01 |
| Summary: | summary |