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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 700 CX Penile Prosthesis; 700 CX Preconnected Penile Prosthes; 700 CXR Preconnected Penile Prosthe; 700 Supplemental Components; 700 Ultrex Penile Prosthesis; 700 Ultrex Preconnected Penile Pros; AMS 700 MS Series Penile Prostheses; AMS 700 Select Series Non-IZ; AMS 700 Series with Tactile Pump
Classification Name: PROSTHESIS, PENIS, INFLATABLE
Product Code: JCW
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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