GLUCANPRO

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

BRENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Glucanpro.

Pre-market Notification Details

Device IDK000519
510k NumberK000519
Device Name:GLUCANPRO
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
ContactPhil Lawin
CorrespondentPhil Lawin
BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-16
Decision Date2000-05-01

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