BIOFLOW(TM)

FDA Premarket Approval P800064

Pre-market Approval Supplement Details

DeviceBIOFLOW(TM)
Generic NameGraft, Vascular, Hemodialysis Access, Synthetic/biological Composite
ApplicantGENETIC LABORATORIES, INC.
Date Received1980-12-01
Decision Date1982-03-10
Notice Date1982-07-20
PMAP800064
SupplementS
Product CodeMCI 
Docket Number82M-0094
Advisory CommitteeObstetrics/Gynecology
Expedited ReviewNo
Combination Product No
Applicant Address GENETIC LABORATORIES, INC. 1385 Centennial Drive St. Paul , Minn.  

Supplemental Filings

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Supplement NumberDateSupplement Type
P800064Original Filing

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