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ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153267
510(k) Type
Traditional
Applicant
ORIGIO A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
7/22/2016
Days to Decision
253 days
Submission Type
Summary

ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153267
510(k) Type
Traditional
Applicant
ORIGIO A/S
Country
Denmark
FDA Decision
Substantially Equivalent
Decision Date
7/22/2016
Days to Decision
253 days
Submission Type
Summary