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iSurg

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170054
510(k) Type
Abbreviated
Applicant
JACO, LLC dba Macan Manufacturing and BNA Burz North America
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/2/2017
Days to Decision
269 days
Submission Type
Summary

iSurg

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K170054
510(k) Type
Abbreviated
Applicant
JACO, LLC dba Macan Manufacturing and BNA Burz North America
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/2/2017
Days to Decision
269 days
Submission Type
Summary