AURORA— 510(k) K063003

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K063003 for AURORA, Substantially Equivalent on 2006-11-28. Applicant: Parkell, Inc..

Clearance details

Applicant: Parkell, Inc.
Product code: Code EBZ
Advisory panel: Dental
Date received: 2006-10-02
Decision date: 2006-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgewood, NY, US

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