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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceBIOFLOW(TM)
Generic NameGraft, vascular, hemodialysis access, synthetic/biological composite
ApplicantGenetic Laboratories, Inc.
1385 Centennial Dr. St. Paul
, Minn. 
PMA NumberP800064
Date Received12/01/1980
Decision Date03/10/1982
Product Code MCI 
Docket Number 82M-0094
Notice Date 07/20/1982
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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