MammoGRIP— 510(k) K152038
Substantially EquivalentWomen'S Imaging Solutions Enterprises, LLC
FDA 510(k) clearance K152038 for MammoGRIP, Substantially Equivalent on 2015-12-22. Applicant: Women'S Imaging Solutions Enterprises, LLC. Device class: 2.
Clearance details
- Applicant
- Women'S Imaging Solutions Enterprises, LLC
- 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
- Traditional
- Location
- Cresskill, NJ, US
Recent devices under product code IZH
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