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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.
 
Trade NameCOMPOSITE CULTURED SKIN
Classification Namecomposite cultured skin
Generic Namecomposite cultured skin
Regulation Number878.4024
Applicant
ORTEC INTL., INC.
3960 broadway, 2nd flr.
new york, NY 10032
HDE NumberH990013
Date Received11/22/1999
Decision Date02/21/2001
Product Code
PBD
Docket Number 01M-0201
Advisory Committee General & Plastic Surgery
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Composite cultured skin is indicated for use in patients with mitten hand deformities due to recessive dystrophic epidermolysis bullosa (rdeb) as an adunct to standard autograft procedures (i. E. , skin grafts and flaps) for covering wounds and donor sites created after surgical release of hand contractures (i. E. , "mitten" hand deformities).
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S003 S004 
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