Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.

• Classification Name: composite cultured skin
• Generic Name: pbd
• Regulation Number: 878.4024
• Applicant: Ortec International, Inc.; 3960 broadway, 2nd floor; new yoir, NY 10032
• HDE Number: BH991300
• Supplement Number: 3
• Date Received: 08/02/2001
• Decision Date: 10/16/2001
• Product Code: PBD
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No