BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE— 510(k) K970930

Name: FDA 510(k) clearance K970930
Creator: U.S. Food and Drug Administration
Published: 1997-04-23

Substantially Equivalent

Cleft Palate Appliances, Inc.

FDA 510(k) clearance K970930 for BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE, Substantially Equivalent on 1997-04-23. Applicant: Cleft Palate Appliances, Inc.. Device class: 1.

Clearance details

Applicant: Cleft Palate Appliances, Inc.
Product code: Code DYJ
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1997-03-13
Decision date: 1997-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, CA

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