The following data is part of a premarket notification filed by Spectra Medical Devices with the FDA for Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford.
| Device ID | K163292 |
| 510k Number | K163292 |
| Device Name: | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SPECTRA MEDICAL DEVICES 260-H FORDHAM ROAD Wilmington, MA 01887 |
| Contact | Scott Henderson |
| Correspondent | Jame4s Wason Maelor Group, Inc 7 Village Woods Dr Amherst, NH 03031 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2017-09-08 |
| Summary: | summary |