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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Assufil Monofilamento; E-LOC Endo360 suture; Filbloc
Classification Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Product Code: NEW
Device Class: 2
Regulation Number: 878.4840
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Assut Europe S.P.A.
Registered Establishment Number: 9617547
Premarket Submission Number: K150553
Owner/Operator: ASSUT EUROPE S.P.A.
Owner/Operator Number: 9044488
Establishment Operations: Manufacturer
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