The following data is part of a premarket notification filed by Devicor Medical Products, Inc. with the FDA for Mammotome Reolve Dual Vacuum Assisted Biopsy (vab) System.
| Device ID | K123259 |
| 510k Number | K123259 |
| Device Name: | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | DEVICOR MEDICAL PRODUCTS, INC. 300 E-BUSINESS WAY, FIFTH FLOOR Cincinnati, OH 45241 |
| Contact | Shawna M Rose |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-10-18 |
| Decision Date | 2012-11-15 |
| Summary: | summary |