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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PuraStat
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, LTD.
Registered Establishment Number: 3007162658
Premarket Submission Number: K210098
Owner/Operator: 3-D Matrix, Ltd.
Owner/Operator Number: 10061211
Establishment Operations: Foreign Exporter
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