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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
Device Orcel
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
Ortec International, Inc.
3960 broadway, 2nd floor
New Yoir , NY 10032 
  
PMA NumberBP011600
Date Received03/05/2001
Decision Date08/31/2001
Decision Approved
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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