The following data is part of a premarket notification filed by Suros Surgical Systems, Inc. with the FDA for Vacuum Assisted Core Biopsy Device.
| Device ID | K034021 |
| 510k Number | K034021 |
| Device Name: | VACUUM ASSISTED CORE BIOPSY DEVICE |
| Classification | Instrument, Biopsy |
| Applicant | SUROS SURGICAL SYSTEMS, INC. 9502 ANGOLA COURT SUITE 3 Indianapolis, IN 46268 |
| Contact | Joseph L Mark |
| Correspondent | Joseph L Mark SUROS SURGICAL SYSTEMS, INC. 9502 ANGOLA COURT SUITE 3 Indianapolis, IN 46268 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05420045503222 | K034021 | 000 |
| 15420045504929 | K034021 | 000 |