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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 NameDERMAGRAFT (DYSTROPHIC EPIDERMOLYSIS BULLOSA)
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
Advanced Biohealing, Inc.
10933 n. torrey pines rd.
la jolla, CA 92037
HDE NumberH020004
Supplement NumberS002
Date Received06/13/2006
Decision Date08/09/2006
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 ProductYes
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