510(k) K220957

Device
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Applicant
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510(k) number
K220957
Product code
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Decision
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Decision date
2022-11-10
Date received
2022-04-01
Regulation
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Classification name
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Medical specialty
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Review panel
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Device class
2
Clearance type
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Statement or summary
Summary
Third party reviewed
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Applicant Contact#

Contact
Randy Vader
Address
798 Miyanodai Kaisei-Machi Ashigara Kami-Gun JP 258-8538 258-8538

FDA Registration Numbers#

Source Documents#

510(k) summary PDF