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Max.(㎛) Max.(㎛) Avg.(㎛)
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(ISO 14607. ASTM F703, FDA Guidance).

ISO 14067 - Non-active surgical implants -- Mammary implants -- Particular requirements ASTM F703 - Standard Specification
for Implantable Breast Prostheses RDA GUIDANCE - Saline, Silicone Gel, and Alternative Breast Implants
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As a medical device, “Precautions” and “Method of Use” must be read carefully before usage.
KMDIA : Deliberation No. 2017-11-04-02624

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