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PaX-i3D Green Premium (Model: PCT-90LH)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160882
510(k) Type
Traditional
Applicant
VATECH CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/28/2016
Days to Decision
211 days
Submission Type
Summary

PaX-i3D Green Premium (Model: PCT-90LH)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160882
510(k) Type
Traditional
Applicant
VATECH CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
10/28/2016
Days to Decision
211 days
Submission Type
Summary