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PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K092593
510(k) Type
Traditional
Applicant
ATOS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent - Kit
Decision Date
10/14/2010
Days to Decision
416 days
Submission Type
Summary

PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K092593
510(k) Type
Traditional
Applicant
ATOS MEDICAL AB
Country
Sweden
FDA Decision
Substantially Equivalent - Kit
Decision Date
10/14/2010
Days to Decision
416 days
Submission Type
Summary