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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BioGlue (R) Surgical Adhesive
Classification Name: GLUE, SURGICAL, ARTERIES
Product Code: MUQ
Device Class: 3
Registered Establishment Name: Artivion, Inc.
Registered Establishment Number: 1063481
Premarket Submission Number: P010003
Owner/Operator: Artivion, Inc.
Owner/Operator Number: 9003683
Establishment Operations: Manufacturer; Complaint File Establishment
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