EXTRAORAL HEADGEAR— 510(k) K936151

Substantially Equivalent

Dentauraum, Inc.

FDA 510(k) clearance K936151 for EXTRAORAL HEADGEAR, Substantially Equivalent on 1994-08-01. Applicant: Dentauraum, Inc.. Device class: 2.

Clearance details

Applicant: Dentauraum, Inc.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1993-12-27
Decision date: 1994-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Dentauraum, Inc.

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