FDA-Device2014-12-03Class II
Dharma Cavity Varnish 15mL
Dharma Research, Inc.
Hazard
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Sold states
Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates.
Affected count
916
Manufactured in
5220 Nw 72nd Ave, Bay 15, Miami, FL, United States
Products
Dharma Cavity Varnish 15mL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0476-2015Don't want to check this manually?
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