BURN JEL PLUS

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

WATER-JEL TECHNOLOGIES, LLC.

The following data is part of a premarket notification filed by Water-jel Technologies, Llc. with the FDA for Burn Jel Plus.

Pre-market Notification Details

Device IDK003396
510k NumberK003396
Device Name:BURN JEL PLUS
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant WATER-JEL TECHNOLOGIES, LLC. 243 VETERANS BLVD. Carlstadt,  NJ  07072
ContactMichael Pisani
CorrespondentMichael Pisani
WATER-JEL TECHNOLOGIES, LLC. 243 VETERANS BLVD. Carlstadt,  NJ  07072
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-11-01
Decision Date2001-01-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00743537001217 K003396 000
00743537001200 K003396 000
00743537001088 K003396 000
00743537001064 K003396 000
00743537001040 K003396 000
00743537001002 K003396 000
00743537000920 K003396 000
00743537000906 K003396 000
00743537000845 K003396 000

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