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UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183263
510(k) Type
Traditional
Applicant
UNiPACK Medical Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/14/2019
Days to Decision
203 days
Submission Type
Summary

UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183263
510(k) Type
Traditional
Applicant
UNiPACK Medical Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/14/2019
Days to Decision
203 days
Submission Type
Summary