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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, INC.
Registered Establishment Number: 3015528146
Premarket Submission Number: K210098
Owner/Operator: 3D-Matrix
Owner/Operator Number: 10060325
Establishment Operations: Manufacturer; Complaint File Establishment
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