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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 3D-Shaper
Classification Name: DENSITOMETER, BONE
Product Code: KGI
Device Class: 2
Regulation Number: 892.1170
Medical Specialty: Radiology
Registered Establishment Name: 3D-SHAPER MEDICAL S.L.
Registered Establishment Number: 3026043045
Premarket Submission Number: K220822
Owner/Operator: 3D-Shaper Medical S.L.
Owner/Operator Number: 10087195
Establishment Operations: Manufacturer
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