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ManaFlexx 2 (model: MF002-RX, MF002-OTC)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231569
510(k) Type
Traditional
Applicant
ManaMed, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/2023
Days to Decision
156 days
Submission Type
Summary

ManaFlexx 2 (model: MF002-RX, MF002-OTC)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231569
510(k) Type
Traditional
Applicant
ManaMed, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/3/2023
Days to Decision
156 days
Submission Type
Summary