The following data is part of a premarket notification filed by Synaptive Medical Inc. with the FDA for Brightmatter Guide With Brightmatter Pointer.
| Device ID | K160523 |
| 510k Number | K160523 |
| Device Name: | BrightMatter Guide With BrightMatter Pointer |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SYNAPTIVE MEDICAL INC. MARS CENTER, SOUTH TOWER, 101 COLLEGE STREET, SUITE 200 Toronto, CA M5g 1l7 |
| Contact | Cameron Piron |
| Correspondent | Allison Komiyama ACKNOWLEDGE REGULATORY STRATEGIES 2834 HAWTHORN ST. San Diego, CA 92104 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-25 |
| Decision Date | 2016-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00670082000108 | K160523 | 000 |
| 00670082000092 | K160523 | 000 |