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CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111047
510(k) Type
Special
Applicant
MAUNA KEA TECHNOLOGIES INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2011
Days to Decision
115 days
Submission Type
Summary

CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111047
510(k) Type
Special
Applicant
MAUNA KEA TECHNOLOGIES INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/8/2011
Days to Decision
115 days
Submission Type
Summary