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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: DemeDIOX Barbed with Novathreads-Absorbable Polydioxane Surgical Suture; DemeDIOX with Novathreads-Absorbable Polydioxane Surgical Suture
Classification Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Product Code: NEW
Device Class: 2
Regulation Number: 878.4840
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: DEMETECH CORP.
Registered Establishment Number: 1064584
Premarket Submission Number: K181582
Owner/Operator: DEMETECH CORP.
Owner/Operator Number: 9041973
Establishment Operations: Manufacturer
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