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FDA 510(k), K192105, Innonix Antiviral Child's Face Mask
FDA 510(k), K192105, Innonix Antiviral Child's Face Mask
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$149.00 USD
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$149.00 USD
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510(K) Number: K192105
Device Name: Innonix Antiviral Child's Face Mask
Manufacturer: Tommy Lui
Device Classification Name: Surgical Mask With Antimicrobial/Antiviral Agent
Regulation Number: OUK
Classification Product Code: 08/05/2019
Date Received: 11/29/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Innonix Antiviral Child's Face Mask
Manufacturer: Tommy Lui
Device Classification Name: Surgical Mask With Antimicrobial/Antiviral Agent
Regulation Number: OUK
Classification Product Code: 08/05/2019
Date Received: 11/29/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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