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FDA 510(k), K202831, The iMask Child's Face Mask
FDA 510(k), K202831, The iMask Child's Face Mask
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510(K) Number: K202831
Device Name: The iMask Child's Face Mask
Manufacturer: Pac-Dent, Inc.
Device Classification Name: Pediatric/Child Facemask
Regulation Number: 878.4040
Classification Product Code: OXZ
Date Received: 09/25/2020
Decision Date: 08/26/2021
Regulation Medical Specialty: General & Plastic Surgery
Device Name: The iMask Child's Face Mask
Manufacturer: Pac-Dent, Inc.
Device Classification Name: Pediatric/Child Facemask
Regulation Number: 878.4040
Classification Product Code: OXZ
Date Received: 09/25/2020
Decision Date: 08/26/2021
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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