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ERB ENDORECTAL BALLOON

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141958
510(k) Type
Traditional
Applicant
EDGE MEDICAL LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/18/2014
Days to Decision
123 days
Submission Type
Summary

ERB ENDORECTAL BALLOON

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141958
510(k) Type
Traditional
Applicant
EDGE MEDICAL LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/18/2014
Days to Decision
123 days
Submission Type
Summary