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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE
Product Code: QAU
Device Class: 2
Regulation Number: 878.4456
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: 3-D MATRIX EUROPE SAS
Registered Establishment Number: 3012263097
Premarket Submission Number: K222481
Owner/Operator: 3-D MATRIX EUROPE SAS
Owner/Operator Number: 10084567
Establishment Operations: Specification Developer
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