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Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

Page Type
Cleared 510(K)
510(k) Number
K181756
510(k) Type
Traditional
Applicant
AprioMed AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
12/18/2018
Days to Decision
169 days
Submission Type
Summary

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

Page Type
Cleared 510(K)
510(k) Number
K181756
510(k) Type
Traditional
Applicant
AprioMed AB
Country
Sweden
FDA Decision
Substantially Equivalent
Decision Date
12/18/2018
Days to Decision
169 days
Submission Type
Summary