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Sterile Water for Inhalation in 1L Flexoval ® bottles.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223551
510(k) Type
Traditional
Applicant
Hometa Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/2023
Days to Decision
251 days
Submission Type
Summary

Sterile Water for Inhalation in 1L Flexoval ® bottles.

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223551
510(k) Type
Traditional
Applicant
Hometa Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/3/2023
Days to Decision
251 days
Submission Type
Summary