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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Sientra Silicone Gel Breast Implants
Classification Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
Product Code: FTR
Device Class: 3
Regulation Number: 878.3540
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: SIENTRA, INC
Registered Establishment Number: 1651189
Owner/Operator: SIENTRA, INC
Owner/Operator Number: 9106599
Establishment Operations: Specification Developer
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