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Powered Breast Pump (Models 7V and 7X)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211016
510(k) Type
Traditional
Applicant
Haenim Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/29/2022
Days to Decision
450 days
Submission Type
Summary

Powered Breast Pump (Models 7V and 7X)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K211016
510(k) Type
Traditional
Applicant
Haenim Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/29/2022
Days to Decision
450 days
Submission Type
Summary