GENTAL PULSE— 510(k) K950238

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K950238 for GENTAL PULSE, Substantially Equivalent on 1995-05-09. Applicant: Parkell, Inc.. Device class: 2.

Clearance details

Applicant: Parkell, Inc.
Product code: Code EAT
Device class: Class 2
Regulation: 21 CFR 872.1720
Advisory panel: Dental
Date received: 1995-01-20
Decision date: 1995-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.