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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: InFast Ultra Sling System
Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER
Product Code: GAS
Device Class: 2
Regulation Number: 878.5000
Medical Specialty: General & Plastic Surgery
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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