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 |