The following data is part of a premarket notification filed by Xpress Bcd, Llc with the FDA for Xpress Bcd Breast Compression Device.
| Device ID | K163388 |
| 510k Number | K163388 |
| Device Name: | XPress BCD Breast Compression Device |
| Classification | Post Breast Biopsy Hemostatic Breast Compression Device |
| Applicant | XPress BCD, LLC 6024 White Flint Drive Frederick, MD 21702 |
| Contact | Peter Kremers |
| Correspondent | Peter Kremers XPress BCD, LLC 6024 White Flint Drive Frederick, MD 21702 |
| Product Code | POY |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-02 |
| Decision Date | 2017-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008878335 | K163388 | 000 |
| 00860008878328 | K163388 | 000 |
| 00860008878311 | K163388 | 000 |
| 00860008878304 | K163388 | 000 |