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#
- 3024021261
- 1221485
- 9681147
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