The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Mammotome Biopsy System For Molecular Imaging.
| Device ID | K093899 |
| 510k Number | K093899 |
| Device Name: | MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING |
| Classification | Instrument, Biopsy |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Asifa Vonhof |
| Correspondent | Asifa Vonhof ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-18 |
| Decision Date | 2010-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841911101260 | K093899 | 000 |
| 00841911101253 | K093899 | 000 |