The following data is part of a premarket notification filed by Devicor Medical Products Inc. with the FDA for Mammotome Elite Biopsy System.
| Device ID | K112411 |
| 510k Number | K112411 |
| Device Name: | MAMMOTOME ELITE BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | DEVICOR MEDICAL PRODUCTS INC. 300 E. BUSINESS WAY FIFTH FLOOR Cincinnati, OH 45241 -0000 |
| Contact | Shawna M Rose |
| Correspondent | Shawna M Rose DEVICOR MEDICAL PRODUCTS INC. 300 E. BUSINESS WAY FIFTH FLOOR Cincinnati, OH 45241 -0000 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2012-03-20 |
| Summary: | summary |