Proposed instructions for use or electronic instructions for use and labels.] (b) Dat ...

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...

4.0 Design and manufacturing information: 4.1 Device Design: The dossier should conta ...

(f) animal studies that provide direct evidence of safety and performance of the devi ...

PART IV INFORMATION REQUIRED TO BE SUBMITTED WITH THE APPLICATION FORM FOR IMPORT OR ...

(f) animal studies that provide direct evidence of safety and performance of the devi ...

(i) a firm means change from proprietorship to partnership including Limited Liabilit ...

17.0 In use stability: This section should provide information on in use stability st ...