G-CERA ORBIT COLOUR COMMUNICATION SET— 510(k) K932039

Name: FDA 510(k) clearance K932039
Creator: U.S. Food and Drug Administration
Published: 1993-07-08

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K932039 for G-CERA ORBIT COLOUR COMMUNICATION SET, Substantially Equivalent on 1993-07-08. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant: GC America, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 1993-04-27
Decision date: 1993-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

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