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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 NumberS003
Date Received08/02/2001
Decision Date10/16/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a proposed product name change and the final printed labeling.
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