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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 Name Epicel
Classification Namecultured epithelial autograft
Generic Nameoce
Vericel Corporation
64 sidney street
cambridge, MA 02139
HDE NumberBH990200
Supplement Number56
Date Received07/27/2017
Decision Date10/10/2017
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes