BIONECT HYDROGEL FOAM

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

FIDIA PHARMACEUTICAL CORP.

The following data is part of a premarket notification filed by Fidia Pharmaceutical Corp. with the FDA for Bionect Hydrogel Foam.

Pre-market Notification Details

Device IDK973722
510k NumberK973722
Device Name:BIONECT HYDROGEL FOAM
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant FIDIA PHARMACEUTICAL CORP. 2000 K STREET,N.W SUITE 700 Washington,  DC  20006
ContactRoberto Fiorentini
CorrespondentRoberto Fiorentini
FIDIA PHARMACEUTICAL CORP. 2000 K STREET,N.W SUITE 700 Washington,  DC  20006
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-30
Decision Date1998-09-22
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.