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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Flexband; Flexpatch
Classification Name: MESH, SURGICAL, POLYMERIC
Product Code: FTL
Device Class: 2
Regulation Number: 878.3300
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Artelon
Registered Establishment Number: 3033273526
Premarket Submission Number: K230316
Owner/Operator: STRYKER CORP.
Owner/Operator Number: 1811755
Establishment Operations: Manufacturer
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