The following data is part of a premarket notification filed by Inrad with the FDA for Precisecore 10 Mm Biopsy Device- 14ga X 5 Cm Model 670514, 671014, 670518 671018, 670520.
| Device ID | K093399 |
| 510k Number | K093399 |
| Device Name: | PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 |
| 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 | 2009-11-02 |
| Decision Date | 2009-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817295020852 | K093399 | 000 |
| 10817295020739 | K093399 | 000 |
| 10817295020746 | K093399 | 000 |
| 10817295020753 | K093399 | 000 |
| 10817295020760 | K093399 | 000 |
| 10817295020777 | K093399 | 000 |
| 10817295020784 | K093399 | 000 |
| 10817295020791 | K093399 | 000 |
| 10817295020807 | K093399 | 000 |
| 10817295020814 | K093399 | 000 |
| 10817295020821 | K093399 | 000 |
| 10817295020838 | K093399 | 000 |
| 10817295020845 | K093399 | 000 |
| 10817295020722 | K093399 | 000 |