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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Biotronix Healthcare Chromic Catgut Suture with Needle; Biotronix Healthcare Plain Catgut Suture with Needle
Classification Name: SUTURE, ABSORBABLE, NATURAL
Product Code: GAL
Device Class: 2
Regulation Number: 878.4830
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: BIOTRONIX HEALTHCARE INDUSTRIES INC.
Registered Establishment Number: 3010131137
Owner/Operator: Biotronix Healthcare Industries Inc.
Owner/Operator Number: 10043487
Establishment Operations: Repackager/Relabeler
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