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LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080355
510(k) Type
Traditional
Applicant
ELEKTA INSTRUMENT AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
5/1/2009
Days to Decision
445 days
Submission Type
Summary

LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080355
510(k) Type
Traditional
Applicant
ELEKTA INSTRUMENT AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
5/1/2009
Days to Decision
445 days
Submission Type
Summary