SURESEAL BANDAGE

Tape And Bandage, Adhesive

GAINOR MEDICAL EUROPE, LTD.

The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Sureseal Bandage.

Pre-market Notification Details

Device IDK922441
510k NumberK922441
Device Name:SURESEAL BANDAGE
ClassificationTape And Bandage, Adhesive
Applicant GAINOR MEDICAL EUROPE, LTD. 310 HOLDEN SHORE SUTIE 240 Long Beach,  CA  90802
ContactGainor
CorrespondentGainor
GAINOR MEDICAL EUROPE, LTD. 310 HOLDEN SHORE SUTIE 240 Long Beach,  CA  90802
Product CodeKGX  
CFR Regulation Number880.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-22
Decision Date1993-08-10

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