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OP300

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133544
510(k) Type
Special
Applicant
PALODEX GROUP OY
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
3/26/2014
Days to Decision
128 days
Submission Type
Summary

OP300

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K133544
510(k) Type
Special
Applicant
PALODEX GROUP OY
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
3/26/2014
Days to Decision
128 days
Submission Type
Summary