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510(k) Data Aggregation
K Number
K222748Device Name
ShiNeo Silicone Implant
Manufacturer
Shineo Technology Co., Ltd
Date Cleared
2022-12-23
(102 days)
Product Code
MIB, FWP, LZK
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
Shineo Technology Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour
Device Description
ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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