HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP— 510(k) K902646

Name: FDA 510(k) clearance K902646
Creator: U.S. Food and Drug Administration
Published: 1990-09-06

Substantially Equivalent

Ormco Corp.

FDA 510(k) clearance K902646 for HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP, Substantially Equivalent on 1990-09-06. Applicant: Ormco Corp.. Device class: 2.

Clearance details

Applicant: Ormco Corp.
Product code: Code DZB
Device class: Class 2
Regulation: 21 CFR 872.5500
Advisory panel: Dental
Date received: 1990-06-15
Decision date: 1990-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

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