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Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170622
510(k) Type
Special
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2017
Days to Decision
30 days
Submission Type
Summary

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170622
510(k) Type
Special
Applicant
Cook Incorporated
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2017
Days to Decision
30 days
Submission Type
Summary