The following data is part of a premarket notification filed by Minrad, Inc. with the FDA for Light Saber Core Tissue Needle.
| Device ID | K981796 |
| 510k Number | K981796 |
| Device Name: | LIGHT SABER CORE TISSUE NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MINRAD, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Contact | Thomas L Parker |
| Correspondent | Thomas L Parker MINRAD, INC. 6576 EAST QUAKER ST. Orchard Park, NY 14127 -2593 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-21 |
| Decision Date | 1998-08-05 |