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Sterile LeadConfirm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191739
510(k) Type
Traditional
Applicant
Alpha Omega Engineering Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
1/2/2020
Days to Decision
188 days
Submission Type
Summary

Sterile LeadConfirm

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191739
510(k) Type
Traditional
Applicant
Alpha Omega Engineering Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
1/2/2020
Days to Decision
188 days
Submission Type
Summary