The following data is part of a premarket notification filed by Izi Medical Products with the FDA for Navigable Brain Biopsy Cannula Set.
| Device ID | K140705 |
| 510k Number | K140705 |
| Device Name: | NAVIGABLE BRAIN BIOPSY CANNULA SET |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | IZI MEDICAL PRODUCTS 5 EASTER COURT SUITE J Owings Mills, MD 21117 |
| Contact | Qiang Cao |
| Correspondent | Qiang Cao IZI MEDICAL PRODUCTS 5 EASTER COURT SUITE J Owings Mills, MD 21117 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2014-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212020315 | K140705 | 000 |
| 00815212020308 | K140705 | 000 |
| 00815212020292 | K140705 | 000 |
| 00815212020285 | K140705 | 000 |