The following data is part of a premarket notification filed by Inrad Inc. with the FDA for Elitecore Full Core Biopsy Device 18gax10cm, 18gax15cm, 18gax20, With/hilitier 18gax10cm , W/hiliter 18gax15cm.
| Device ID | K112945 |
| 510k Number | K112945 |
| Device Name: | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM |
| Classification | Instrument, Biopsy |
| Applicant | INRAD INC. 4375 DONKER CT SE Grand Rapids, MI 49504 |
| Contact | Ryan Goosen |
| Correspondent | Ryan Goosen INRAD INC. 4375 DONKER CT SE Grand Rapids, MI 49504 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2011-11-03 |
| Summary: | summary |