DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P

Gauze, External (with Drug/biologic/animal Source Material)

DEXIDE, INC.

The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Dis. Prep Sponge W/idex Patient P.

Pre-market Notification Details

Device IDK792273
510k NumberK792273
Device Name:DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P
ClassificationGauze, External (with Drug/biologic/animal Source Material)
Applicant DEXIDE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGER  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-11-13
Decision Date1979-12-10

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