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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: ETHI-PACK* PRE-CUT SUTURE
Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Product Code: GAR
Device Class: 2
Regulation Number: 878.5020
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ETHICON, INC.
Registered Establishment Number: 2210968
Premarket Submission Number: K931271
Owner/Operator: ETHICON INC.
Owner/Operator Number: 2210968
Establishment Operations: Manufacturer
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