The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Spectra Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle.
| Device ID | K151069 |
| 510k Number | K151069 |
| Device Name: | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SPECTRA MEDICAL DEVICES, INC. 260 F/H Fordham Road Wilmington, MA 01887 |
| Contact | Agustin Turriza |
| Correspondent | Tanya O'brien AJW Technology Consultants, Inc. 445 Apollo Beach Blvd Apollo Beach, FL 33572 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-21 |
| Decision Date | 2016-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M661S80C21400 | K151069 | 000 |
| M661S80C21200 | K151069 | 000 |
| M661S90C22600 | K151069 | 000 |
| M661S80C23200 | K151069 | 000 |
| M661S80C22200 | K151069 | 000 |
| M661S80C21600 | K151069 | 000 |