The following data is part of a premarket notification filed by Invivo Therapeutics Corporation with the FDA for Ds Small Extremity 16ch 1.5t Coil.
| Device ID | K162863 |
| 510k Number | K162863 |
| Device Name: | DS Small Extremity 16CH 1.5T Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | INVIVO THERAPEUTICS CORPORATION 3545 SW 47th Ave Gainesville, FL 32608 |
| Contact | Ken Revennaugh |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-10-13 |
| Decision Date | 2016-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087408 | K162863 | 000 |
| 00884838086401 | K162863 | 000 |
| 00884838081666 | K162863 | 000 |
| 00884838081659 | K162863 | 000 |