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GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050963
510(k) Type
Special
Applicant
MDS NORDION
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
5/20/2005
Days to Decision
32 days
Submission Type
Summary

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050963
510(k) Type
Special
Applicant
MDS NORDION
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
5/20/2005
Days to Decision
32 days
Submission Type
Summary