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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 NameEPICEL (CULTURED EPIDERMAL AUTOGRAFTS)
Classification Namecultured epithelial autograft
Generic Namecultured epithelial autograft
Applicant
GENZYME CORP.
200 crossing blvd
framingham, MA 01702
HDE NumberH990002
Supplement NumberS002
Date Received06/11/2008
Decision Date07/11/2008
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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