The following data is part of a premarket notification filed by Laurus Medical Corp. with the FDA for Stereotactic Needle Core Biopsy System.
| Device ID | K973215 |
| 510k Number | K973215 |
| Device Name: | STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | LAURUS MEDICAL CORP. 10 CHRYSLER, SUITE B Irvine, CA 92618 |
| Contact | Richard A Basler |
| Correspondent | Richard A Basler LAURUS MEDICAL CORP. 10 CHRYSLER, SUITE B Irvine, CA 92618 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-27 |
| Decision Date | 1997-11-06 |