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RectalPro 75 Endorectal Balloon

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180478
510(k) Type
Traditional
Applicant
QLRAD International Ltd.
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
11/13/2018
Days to Decision
264 days
Submission Type
Summary

RectalPro 75 Endorectal Balloon

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180478
510(k) Type
Traditional
Applicant
QLRAD International Ltd.
Country
Netherlands
FDA Decision
Substantially Equivalent
Decision Date
11/13/2018
Days to Decision
264 days
Submission Type
Summary