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FDA 510(k), K160377, V-varnish Premium
FDA 510(k), K160377, V-varnish Premium
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510(K) Number: K160377
Device Name: V-varnish Premium
Manufacturer: Myung-Hwan Oh
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: KXA
Date Received: 02/10/2016
Decision Date: 12/02/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: V-varnish Premium
Manufacturer: Myung-Hwan Oh
Device Classification Name: Varnish, Cavity
Regulation Number: LBH
Classification Product Code: KXA
Date Received: 02/10/2016
Decision Date: 12/02/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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