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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: SUTUREGARD™ Device; SUTUREGARD™ tissue expansion device
Classification Name: RETENTION DEVICE, SUTURE
Product Code: KGS
Device Class: 1
Regulation Number: 878.4930
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: SUTUREGARD MEDICAL, INC.
Owner/Operator: SUTUREGARD Medical, Inc.
Owner/Operator Number: 10058863
Establishment Operations: Manufacturer; Complaint File Establishment
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