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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: A.M.I. OptiClean Device 285 / AOC 4; A.M.I. OptiClean Device 305 / AOC 4; A.M.I.-dock Easy Loop DLU / A05 451
Classification Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Product Code: GAM
Device Class: 2
Regulation Number: 878.4493
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: AGENCY FOR MEDICAL INNOVATIONS GMBH
Registered Establishment Number: 3005049530
Owner/Operator: AGENCY FOR MEDICAL INNOVATIONS GMBH
Owner/Operator Number: 9068871
Establishment Operations: Manufacturer
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