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HYBERNITE RAINOUT CONTROL SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100104
510(k) Type
Traditional
Applicant
PLASTIFLEX GROUP NV
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/14/2010
Days to Decision
91 days
Submission Type
Summary

HYBERNITE RAINOUT CONTROL SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100104
510(k) Type
Traditional
Applicant
PLASTIFLEX GROUP NV
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/14/2010
Days to Decision
91 days
Submission Type
Summary