510(k) K163388
- Device
- XPress BCD Breast Compression Device
- Applicant
- XPress BCD, LLC
- 510(k) number
- K163388
- Product code
- POY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-19
- Date received
- 2016-12-02
- Regulation
- 892.1710
- Classification name
- Post Breast Biopsy Hemostatic Breast Compression Device
- Medical specialty
- Radiology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Peter Kremers
- Address
- 6024 White Flint Dr. Frederick MD US 21702 21702
FDA Registration Numbers#
- 3026674642
Source Documents#
Legacy Summary#
summary
FDA Review#
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