FDA 510(k), K191103, Parkell Desensitizer Gel

FDA 510(k), K191103, Parkell Desensitizer Gel

Regular price $89.00 USD
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510(K) Number: K191103
Device Name: Parkell Desensitizer Gel
Manufacturer: David Mott
Device Classification Name: Liner, Cavity, Calcium Hydroxide
Regulation Number: EJK
Classification Product Code: KXA
Date Received: 04/25/2019
Decision Date: 11/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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