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SINGLE USE BALLOON DILATOR MAXPASSTM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050502
510(k) Type
Traditional
Applicant
OLYMPUS WINTER & IBE GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/8/2005
Days to Decision
130 days
Submission Type
Summary

SINGLE USE BALLOON DILATOR MAXPASSTM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050502
510(k) Type
Traditional
Applicant
OLYMPUS WINTER & IBE GMBH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/8/2005
Days to Decision
130 days
Submission Type
Summary