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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Product Code: NEW
Device Class: 2
Regulation Number: 878.4840
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: COSMOFRANCE
Registered Establishment Number: 3007895168
Premarket Submission Number: K160761
Owner/Operator: COSMOFRANCE
Owner/Operator Number: 10032329
Establishment Operations: Repackager/Relabeler; Complaint File Establishment
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