The following data is part of a premarket notification filed by Nanotherapeutics, Inc. with the FDA for Nanofuse Dbm.
| Device ID | K142104 |
| 510k Number | K142104 |
| Device Name: | NANOFUSE DBM |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | NANOTHERAPEUTICS, INC. 13859 PROGRESS BLVD, SUITE 300 Alachua, FL 32615 |
| Contact | Doris Snow |
| Correspondent | Doris Snow NANOTHERAPEUTICS, INC. 13859 PROGRESS BLVD, SUITE 300 Alachua, FL 32615 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-01 |
| Decision Date | 2015-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858686006072 | K142104 | 000 |
| 00858686006065 | K142104 | 000 |
| 00858686006058 | K142104 | 000 |
| 00858686006041 | K142104 | 000 |
| 00858686006034 | K142104 | 000 |
| 00858686006027 | K142104 | 000 |
| 00858686006010 | K142104 | 000 |
| 00858686006003 | K142104 | 000 |