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ONTEX AND OTHER PROPRIETARY NAMES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122603
510(k) Type
Traditional
Applicant
ONTEX BVBA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2012
Days to Decision
114 days
Submission Type
Summary

ONTEX AND OTHER PROPRIETARY NAMES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K122603
510(k) Type
Traditional
Applicant
ONTEX BVBA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2012
Days to Decision
114 days
Submission Type
Summary