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510(k) Data Aggregation
K Number
K071823Device Name
PERMA FACIAL IMPLANTS
Manufacturer
Date Cleared
2007-09-19
(78 days)
Product Code
Regulation Number
878.3500Why did this record match?
Applicant Name (Manufacturer) :
SURGISIL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Perma Facial Implants are solid silicone implants that are intended for use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections in the face, including areas such as the nose, chin, and cheeks.
Device Description
The SurgiSil™ Perma Facial Implants are injection-molded (pre-formed) silicone implants with a hardness of 40 on the shore "00" scale. The SurgiSil™ Perma Facial Implants have a cylindrical shape with tapered ends. The implants will be provided in various sizes, with diameters of 2-6 mm and lengths of 50-75 mm. The Perma Facial Implants are individually packaged and sterilized by gamma irradiation and are labeled for single use. The Perma Facial Implants are designed with tapered ends to reduce visibility of the implant ends following implantation. The smooth surface of the implant prevents tissue ingrowth permitting easy removal and/or exchange of the implant. The Perma Facial Implants are ideal for use in soft tissue augmentation anywhere in the face where, in the physician's experience, use of a soft silicone elastomer is appropriate.
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