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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade Name Epicel
Classification Namecultured epithelial autograft
Generic Nameoce
Applicant
Vericel Corporation
64 sidney street
cambridge, MA 02139
HDE NumberBH990200
Date Received02/05/1999
Decision Date10/25/2007
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
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