WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL

Transducer, Ultrasonic, Diagnostic

NATIONAL THERAPY PRODUCTS INC.

The following data is part of a premarket notification filed by National Therapy Products Inc. with the FDA for Wavelength Multi-purpose Ultrasound Gel.

Pre-market Notification Details

Device IDK012522
510k NumberK012522
Device Name:WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant NATIONAL THERAPY PRODUCTS INC. 2-191 ROWNTREE DAIRY RD. Woodbridge, Ontario,  CA Lhl 8b8
ContactPaul L Hooey
CorrespondentPaul L Hooey
NATIONAL THERAPY PRODUCTS INC. 2-191 ROWNTREE DAIRY RD. Woodbridge, Ontario,  CA Lhl 8b8
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-06
Decision Date2001-10-18

NIH GUDID Devices

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