GENERAL AND PLASTIC SURGERY DEVICES PANEL

July 17, 2001

Briefing Information

FDA Preclinical Summary   pdf    htm   doc

FDA Clinical Summary   pdf   htm   doc

FDA Statistical Summary   pdf   htm   doc

Ortec International Inc

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.


Summary of Safety and Effectiveness   pdf    doc

Labeling   pdf  doc

Clinical Report, Part 1   pdf   doc

Clinical Report, Part 2   pdf   doc

Clinical Report, Part 3   pdf   doc

Clinical Report, Part 4   pdf  doc