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- ESIPolymer, Natural-Absorbable Gelatin Material3Product Code
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
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- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Eustachi Ear Pressure Relief Device
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K203754
- 510(k) Type
- Traditional
- Applicant
- Exercore, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/19/2021
- Days to Decision
- 58 days
- Submission Type
- Summary