EAZY PRIMER— 510(k) K142848
Substantially EquivalentParkell, Inc.
FDA 510(k) clearance K142848 for EAZY PRIMER, Substantially Equivalent on 2015-02-24. Applicant: Parkell, Inc.. Device class: 2.
Clearance details
- Applicant
- Parkell, Inc.
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edgewood, NY, US
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