BRENNEN MEDICAL BETA GLUCAN GEL

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 Brennen Medical Beta Glucan Gel.

Pre-market Notification Details

Device IDK982825
510k NumberK982825
Device Name:BRENNEN MEDICAL BETA GLUCAN GEL
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
ContactKenneth B Herland
CorrespondentKenneth B Herland
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 Received1998-08-11
Decision Date1998-11-06

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