The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Llc with the FDA for Nva, Nvp, And Nvt.
| Device ID | K162426 |
| 510k Number | K162426 |
| Device Name: | Nva, Nvp, And Nvt |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NVISION BIOMEDICAL TECHNOLOGIES, LLC 1350 N LOOP 1604 E, SUITE 103 San Antonio, TX 78232 |
| Contact | Diana L. Langham |
| Correspondent | Allison Komiyama ACKNOWLEDGE REGULATORY STRATEGIES 2834 HAWTHORN ST. San Diego, CA 92104 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2016-09-29 |
| Summary: | summary |