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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PuraGel; PuraSinus
Classification Name: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
Product Code: NHB
Device Class: 2
Regulation Number: 874.3620
Medical Specialty: Ear Nose & Throat
Registered Establishment Name: 3-D MATRIX, INC.
Registered Establishment Number: 3015528146
Premarket Submission Number: K183015
Owner/Operator: 3D-Matrix
Owner/Operator Number: 10060325
Establishment Operations: Manufacturer; Complaint File Establishment
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