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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 NameCOMPOSITE 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 NumberS001
Date Received05/23/2001
Decision Date06/14/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Modify product manufacture to include fibroblast cells (bs143f05) expanded to passage 4.
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