The following data is part of a premarket notification filed by Promex Technologies, Llc with the FDA for Full Core Biopsy System.
| Device ID | K111765 |
| 510k Number | K111765 |
| Device Name: | FULL CORE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | PROMEX TECHNOLOGIES, LLC 9001 WESLEYAN ROAD Indianapolis, IN 46268 |
| Contact | Allison Scott |
| Correspondent | Allison Scott PROMEX TECHNOLOGIES, LLC 9001 WESLEYAN ROAD 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 | 2011-06-23 |
| Decision Date | 2011-09-06 |
| Summary: | summary |