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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Coaptite Injectable Implant
Classification Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Product Code: LNM
Device Class: 3
Registered Establishment Name: Merz North America, Inc.
Registered Establishment Number: 2135225
Owner/Operator: Merz North America, Inc.
Owner/Operator Number: 9043404
Establishment Operations: Manufacturer; Specification Developer
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