The following data is part of a premarket notification filed by Ethicon Endo-sugery, Llc with the FDA for Mammomark, Mammomark Mr And Cormark Biopsy Site Identifiers.
| Device ID | K082278 |
| 510k Number | K082278 |
| Device Name: | MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS |
| Classification | Marker, Radiographic, Implantable |
| Applicant | ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Carol Hubbard |
| Correspondent | Carol Hubbard ETHICON ENDO-SUGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
| Product Code | NEU |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-11 |
| Decision Date | 2008-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911101687 | K082278 | 000 |
| 10841911100499 | K082278 | 000 |
| 10841911100482 | K082278 | 000 |
| 10841911100475 | K082278 | 000 |
| 10841911100468 | K082278 | 000 |
| 10841911100451 | K082278 | 000 |
| 10841911100444 | K082278 | 000 |
| 10841911100437 | K082278 | 000 |
| 10841911100420 | K082278 | 000 |
| 10841911100413 | K082278 | 000 |
| 10841911100512 | K082278 | 000 |
| 10841911100529 | K082278 | 000 |
| 10841911101373 | K082278 | 000 |
| 10841911101670 | K082278 | 000 |
| 10841911101663 | K082278 | 000 |
| 10841911101656 | K082278 | 000 |
| 10841911101649 | K082278 | 000 |
| 10841911101632 | K082278 | 000 |
| 10841911101625 | K082278 | 000 |
| 10841911101618 | K082278 | 000 |
| 00841911101604 | K082278 | 000 |
| 10841911101595 | K082278 | 000 |
| 10841911100406 | K082278 | 000 |