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AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181814
510(k) Type
Traditional
Applicant
Amsino International, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/4/2018
Days to Decision
57 days
Submission Type
Summary

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K181814
510(k) Type
Traditional
Applicant
Amsino International, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/4/2018
Days to Decision
57 days
Submission Type
Summary