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Cala ONE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN170028
510(k) Type
Direct
Applicant
Cala Health, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
4/26/2018
Days to Decision
344 days

Cala ONE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN170028
510(k) Type
Direct
Applicant
Cala Health, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
4/26/2018
Days to Decision
344 days