The following data is part of a premarket notification filed by Laurus Medical Corp. with the FDA for Laurus Needle Core Biopsy System.
| Device ID | K960317 |
| 510k Number | K960317 |
| Device Name: | LAURUS NEEDLE CORE BIOPSY SYSTEM |
| Classification | Biopsy Needle |
| Applicant | LAURUS MEDICAL CORP. 30 HUGHES SUITE 202 Irvine, CA 92718 |
| Contact | Norman S Gordon |
| Correspondent | Norman S Gordon LAURUS MEDICAL CORP. 30 HUGHES SUITE 202 Irvine, CA 92718 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-23 |
| Decision Date | 1996-03-15 |