The following data is part of a premarket notification filed by Senorx, Inc. with the FDA for Senocor 360 Circumferential Vacuum Assisted Biopsy Device, 8 Gauge.
Device ID | K023923 |
510k Number | K023923 |
Device Name: | SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE |
Classification | Instrument, Biopsy |
Applicant | SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
Contact | Amy Boucly |
Correspondent | Amy Boucly SENORX, INC. 11 COLUMBIA, SUITE A Aliso Viejo, CA 92656 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-25 |
Decision Date | 2002-12-11 |