The following data is part of a premarket notification filed by Inrad with the FDA for Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018.
| Device ID | K093256 |
| 510k Number | K093256 |
| Device Name: | SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 |
| Classification | Instrument, Biopsy |
| Applicant | INRAD 4375 DONKER COURT S.E. Kentwood, MI 49512 |
| Contact | Melissa Lalomia |
| Correspondent | Melissa Lalomia INRAD 4375 DONKER COURT 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 | 2009-10-19 |
| Decision Date | 2009-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817295020715 | K093256 | 000 |
| 10817295020623 | K093256 | 000 |
| 10817295020630 | K093256 | 000 |
| 10817295020647 | K093256 | 000 |
| 10817295020654 | K093256 | 000 |
| 10817295020661 | K093256 | 000 |
| 10817295020678 | K093256 | 000 |
| 10817295020685 | K093256 | 000 |
| 10817295020692 | K093256 | 000 |
| 10817295020708 | K093256 | 000 |
| 10817295020616 | K093256 | 000 |