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HARMONIE SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083577
510(k) Type
Abbreviated
Applicant
STELLATE SYSTEMS
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
8/29/2011
Days to Decision
999 days
Submission Type
Summary

HARMONIE SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083577
510(k) Type
Abbreviated
Applicant
STELLATE SYSTEMS
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
8/29/2011
Days to Decision
999 days
Submission Type
Summary