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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Dome and accessories for saline breast implants Mentor Saline Breast Implant
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: SSP-SiMatrix Inc.
Registered Establishment Number: 3009976880
Owner/Operator: SSP-SiMatrix Inc.
Owner/Operator Number: 10042622
Establishment Operations: Contract Manufacturer
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