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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Sutura PDO Suture
Classification Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
Product Code: NEW
Device Class: 2
Regulation Number: 878.4840
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: SUTURA MEDICAL TECHNOLOGIES LLC
Registered Establishment Number: 3030141376
Premarket Submission Number: K252171
Owner/Operator: Sutura Medical Technologies LLC
Owner/Operator Number: 10096134
Establishment Operations: Specification Developer
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