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AquaFlate Pre-Filled Sterile Water Syringe 10mL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200556
510(k) Type
Traditional
Applicant
HR Pharmaceuticals, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2020
Days to Decision
28 days
Submission Type
Summary

AquaFlate Pre-Filled Sterile Water Syringe 10mL

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200556
510(k) Type
Traditional
Applicant
HR Pharmaceuticals, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/2020
Days to Decision
28 days
Submission Type
Summary