The following data is part of a premarket notification filed by Inrad with the FDA for Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214.
| Device ID | K981166 |
| 510k Number | K981166 |
| Device Name: | ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 |
| Classification | Instrument, Biopsy |
| Applicant | INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Contact | Anne Armstrong |
| Correspondent | Anne Armstrong 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 | 1998-03-31 |
| Decision Date | 1998-06-22 |
| Summary: | summary |