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GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963497
510(k) Type
Traditional
Applicant
NORDION INTERNATIONAL, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
11/8/1996
Days to Decision
66 days
Submission Type
Summary

GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K963497
510(k) Type
Traditional
Applicant
NORDION INTERNATIONAL, INC.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
11/8/1996
Days to Decision
66 days
Submission Type
Summary