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Single Use Balloon Dilator V (with Knife)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150142
510(k) Type
Traditional
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
10/8/2015
Days to Decision
259 days
Submission Type
Summary

Single Use Balloon Dilator V (with Knife)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150142
510(k) Type
Traditional
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
10/8/2015
Days to Decision
259 days
Submission Type
Summary