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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade Name Orcel
Classification Namecomposite cultured skin
Generic Namepbd
Regulation Number878.4024
Applicant
Ortec International, Inc.
3960 broadway, 2nd floor
new yoir, NY 10032
HDE NumberBH991300
Date Received11/22/1999
Decision Date02/21/2001
Product Code
PBD
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
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