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Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153041
510(k) Type
Traditional
Applicant
INTEGRA LIFESCIENCES CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2016
Days to Decision
147 days
Submission Type
Summary

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153041
510(k) Type
Traditional
Applicant
INTEGRA LIFESCIENCES CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/14/2016
Days to Decision
147 days
Submission Type
Summary