GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

GENTELL

The following data is part of a premarket notification filed by Gentell with the FDA for Gentell Hydrogel Spray Gel, Appligard Squeeze.

Pre-market Notification Details

Device IDK990440
510k NumberK990440
Device Name:GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant GENTELL 1667 K ST. N.W., SUITE 700 Washington,  DC  20006 -1608
ContactMark L Itzkoff
CorrespondentMark L Itzkoff
GENTELL 1667 K ST. N.W., SUITE 700 Washington,  DC  20006 -1608
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-11
Decision Date1999-08-12
Summary:summary

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