The following data is part of a premarket notification filed by Spectra Medical Devices with the FDA for Spectra Soft Tissue Biopsy Needles.
| Device ID | K142791 |
| 510k Number | K142791 |
| Device Name: | Spectra Soft Tissue Biopsy Needles |
| Classification | Instrument, Biopsy |
| Applicant | SPECTRA MEDICAL DEVICES 260-F & H FORDHAM ROAD Wilmington, MA 01887 |
| Contact | Agustin Turriza |
| Correspondent | Agustin Turriza SPECTRA MEDICAL DEVICES 260-F & H FORDHAM ROAD Wilmington, MA 01887 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-26 |
| Decision Date | 2015-01-21 |
| Summary: | summary |