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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.
Classification Namecultured epithelial autograft
Generic Namecultured epithelial autograft
200 crossing blvd
framingham, MA 01702
HDE NumberH990002
Supplement NumberS015
Date Received11/21/2012
Decision Date12/16/2014
Product Code
OCE[ Registered Establishments with OCE ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for changing the transport media through the addition of hepes.