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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.
 
Trade NameBIOBRANE(R) II
Classification Namedressing, wound, drug
ApplicantUDL LABORATORIES, INC.
PMA NumberP870069
Date Received11/12/1987
Decision Date10/20/1989
Withdrawal Date 01/19/2010
Product Code
FRO[ Registered Establishments with FRO ]
Docket Number 89M-0491
Notice Date 12/06/1989
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 
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