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- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
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Ear Pressure Relief Device(Model:ER813B)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K230502
- 510(k) Type
- Traditional
- Applicant
- Ningbo Albert Novosino Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/9/2023
- Days to Decision
- 105 days
- Submission Type
- Summary