The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Mammotome Mr Biopsy System.
| Device ID | K042753 |
| 510k Number | K042753 |
| Device Name: | MAMMOTOME MR BIOPSY SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Carol J Sprinkle |
| Correspondent | Carol J Sprinkle ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841911101116 | K042753 | 000 |
| 00841911100584 | K042753 | 000 |
| 00841911100577 | K042753 | 000 |
| 00841911101321 | K042753 | 000 |
| 00841911101314 | K042753 | 000 |
| 00841911101307 | K042753 | 000 |
| 00841911101291 | K042753 | 000 |
| 00841911101369 | K042753 | 000 |
| 00841911101345 | K042753 | 000 |
| 00841911101338 | K042753 | 000 |
| 00841911101888 | K042753 | 000 |
| 00841911101833 | K042753 | 000 |
| 00841911101826 | K042753 | 000 |
| 00841911101802 | K042753 | 000 |
| 00841911100591 | K042753 | 000 |
| 00841911100607 | K042753 | 000 |
| 00841911101109 | K042753 | 000 |
| 00841911101093 | K042753 | 000 |
| 00841911101086 | K042753 | 000 |
| 00841911101079 | K042753 | 000 |
| 00841911101062 | K042753 | 000 |
| 00841911101055 | K042753 | 000 |
| 00841911101048 | K042753 | 000 |
| 00841911101031 | K042753 | 000 |
| 00841911101024 | K042753 | 000 |
| 00841911101017 | K042753 | 000 |
| 00841911101000 | K042753 | 000 |
| 00841911100638 | K042753 | 000 |
| 00841911100621 | K042753 | 000 |
| 00841911101796 | K042753 | 000 |