The following data is part of a premarket notification filed by Nanotherapeutics, Inc. with the FDA for Origen Dbm With Bioactive Glass, Nanofuse Dbm.
| Device ID | K110976 |
| 510k Number | K110976 |
| Device Name: | ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NANOTHERAPEUTICS, INC. 13859 PROGRESS BLVD, SUITE 300 Alachua, FL 32615 |
| Contact | Dennis Tomisaka |
| Correspondent | Dennis Tomisaka NANOTHERAPEUTICS, INC. 13859 PROGRESS BLVD, SUITE 300 Alachua, FL 32615 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-07 |
| Decision Date | 2011-05-03 |
| Summary: | summary |