DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)

Gauze/sponge, Internal

DUMEX MEDICAL SURGICAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Duflex Conforming Bandage (sterile/non-sterile).

Pre-market Notification Details

Device IDK945830
510k NumberK945830
Device Name:DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)
ClassificationGauze/sponge, Internal
Applicant DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario,  CA M1s 3s4
ContactAngelo Guerriero
CorrespondentAngelo Guerriero
DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario,  CA M1s 3s4
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-29
Decision Date1995-01-11

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