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Hybernite RT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151461
510(k) Type
Traditional
Applicant
PLASTIFLEX GROUP NV
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
3/24/2016
Days to Decision
297 days
Submission Type
Summary

Hybernite RT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K151461
510(k) Type
Traditional
Applicant
PLASTIFLEX GROUP NV
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
3/24/2016
Days to Decision
297 days
Submission Type
Summary