Parkell Desensitizer Gel— 510(k) K191103

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K191103 for Parkell Desensitizer Gel, Substantially Equivalent on 2019-11-22. Applicant: Parkell, Inc.. Device class: 2.

Clearance details

Applicant
Parkell, Inc.
Product code
Code EJK
Device class
Class 2
Regulation
21 CFR 872.3250
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Edgewood, NY, US
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