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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received02/05/1999
Decision Date10/25/2007
Product Code
OCE[ Registered Establishments with OCE ]
Docket Number 07M-0415
Notice Date 11/07/2007
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S005 S006 S008 S009 S010 S011 
S012 S013 S014 S015 S016