FDA-Device2022-08-10Class II
CustMbite, Model Number CBT-SRS-UL
Hazard
The device was marketed and sold in the US without FDA clearance.
Sold states
US Nationwide distribution.
Affected count
708
Manufactured in
10100 Linn Station Rd, N/A, Louisville, KY, United States
Products
CustMbite, Model Number CBT-SRS-UL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1494-2022Don't want to check this manually?
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