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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Ambicor Penile Prosthesis + RTEs
Classification Name: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
Product Code: FHW
Device Class: 3
Regulation Number: 876.3350
Medical Specialty: Gastroenterology
Registered Establishment Name: AMERICAN MEDICAL SYSTEMS, INC.
Registered Establishment Number: 2183959
Owner/Operator: AMERICAN MEDICAL SYSTEMS, INC.
Owner/Operator Number: 2126328
Establishment Operations: Manufacturer
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