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Leksell Stereotactic System, Injection/ Aspiration Needle Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152558
510(k) Type
Special
Applicant
ELEKTA INSTRUMENT AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
3/2/2016
Days to Decision
175 days
Submission Type
Statement

Leksell Stereotactic System, Injection/ Aspiration Needle Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K152558
510(k) Type
Special
Applicant
ELEKTA INSTRUMENT AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
3/2/2016
Days to Decision
175 days
Submission Type
Statement