The following data is part of a premarket notification filed by Hologic, Inc with the FDA for Sertera Biopsy Device.
| Device ID | K150169 |
| 510k Number | K150169 |
| Device Name: | Sertera Biopsy Device |
| Classification | Instrument, Biopsy |
| Applicant | Hologic, INC 250 Campus Drive Marlborough, MA 01752 |
| Contact | Brenda Geary |
| Correspondent | Brenda Geary Hologic, INC 250 Campus Drive Marlborough, MA 01752 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25420045504063 | K150169 | 000 |
| 25420045504056 | K150169 | 000 |
| 15420045504066 | K150169 | 000 |
| 15420045504059 | K150169 | 000 |