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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: MENISCAL DART REPAIR SYSTEM
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: DePuy Mitek, Inc.
Registered Establishment Number: 1221934
Premarket Submission Number: K981340
Owner/Operator: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
Owner/Operator Number: 1221934
Establishment Operations: Specification Developer
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