BETA GLUCAN GEL (MACROPRO 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 Beta Glucan Gel (macropro Gel).

Pre-market Notification Details

Device IDK002078
510k NumberK002078
Device Name:BETA GLUCAN GEL (MACROPRO GEL)
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul,  MN  55110
ContactPhillip Lawin
CorrespondentPhillip 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 Received2000-07-10
Decision Date2000-10-02

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