ECOGEL 100 ULTRASOUND GEL

Transducer, Ultrasonic, Diagnostic

ECO-MED PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Eco-med Pharmaceuticals, Inc. with the FDA for Ecogel 100 Ultrasound Gel.

Pre-market Notification Details

Device IDK961757
510k NumberK961757
Device Name:ECOGEL 100 ULTRASOUND GEL
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario,  CA L4w 1h3
ContactPaul L Hooey
CorrespondentPaul L Hooey
ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario,  CA L4w 1h3
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-06
Decision Date1996-07-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00628055650386 K961757 000
05060813630417 K961757 000
05060813630424 K961757 000
00628055650317 K961757 000
00628055650324 K961757 000
00628055650331 K961757 000
00628055650348 K961757 000
00628055650355 K961757 000
00628055650362 K961757 000
00628055650379 K961757 000
05060813630400 K961757 000

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