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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Saline Implants; Siltex Contour Profile Saline Implants; Spectrum Saline Implants
Classification Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Product Code: FWM
Device Class: 3
Regulation Number: 878.3530
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: Mentor Texas LP
Registered Establishment Number: 3005423519
Owner/Operator: MENTOR Worldwide LLC
Owner/Operator Number: 2125050
Establishment Operations: Repackager/Relabeler
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