Cleft Palate Appliances, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Cleft Palate Appliances, Inc. makes
Cleft Palate Appliances, Inc. manufactures bilateral infant cleft palate orthodontic appliances designed to aid in the alignment and correction of cleft palate deformities in infants.
The company’s devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cleft Palate Appliances, Inc. have in the registry?
The registry currently lists 1 device for Cleft Palate Appliances, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cleft Palate Appliances, Inc.'s devices?
Among its 1 most recently registered device, Cleft Palate Appliances, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Cleft Palate Appliances, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cleft Palate Appliances, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Cleft Palate Appliances, Inc. in the registry?
The most recently registered devices listed for Cleft Palate Appliances, Inc. include BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE.