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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: MANI NEEDLE ; SUTURE PACK (PGA SBSORBABLE)
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: ACCUTOME, INC.
Registered Establishment Number: 2521877
Owner/Operator: ACCUTOME, INC.
Owner/Operator Number: 2521877
Establishment Operations: Repackager/Relabeler
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