Affirm Contrast Biopsy— 510(k) K202294
Substantially EquivalentHologic, Inc.
FDA 510(k) clearance K202294 for Affirm Contrast Biopsy, Substantially Equivalent on 2020-10-05. Applicant: Hologic, Inc.. Device class: 2.
Clearance details
- Applicant
- Hologic, Inc.
- Product code
- Code IZH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Danbury, CT, US
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