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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Avitene Microfibrillar Collagen; Avitene Ultrafoam Micofibrillar; Collagen Sponge; Hemostat; SyringeAvitene Preloaded Applicator
Classification Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
Product Code: LMF
Device Class: 3
Regulation Number: 878.4490
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: DAVOL INC., SUB. C.R. BARD, INC.
Registered Establishment Number: 1213643
Owner/Operator: C. R. Bard, Inc.
Owner/Operator Number: 2212754
Establishment Operations: Specification Developer
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