The following data is part of a premarket notification filed by Inrad with the FDA for Accucore Single Action Core Biopsy Device.
| Device ID | K000612 |
| 510k Number | K000612 |
| Device Name: | ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Contact | Joseph M Mazurek |
| Correspondent | Joseph M Mazurek INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-04-24 |