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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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.
 
Trade NameORCEL (TM) (COMPOSITE CULTURED SKIN)
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
Ortec Intl., Inc.
3960 broadway, 2nd flr.
new york, NY 10032
HDE NumberH990013
Supplement NumberS004
Date Received10/22/2001
Decision Date02/06/2002
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Introduction of new cell line, fd-183, into the commercial manufacture of orcel bilayered cellular matrix.
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