THD SLIDE

Monitor, Ultrasonic, Nonfetal

THD SPA

The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Slide.

Pre-market Notification Details

Device IDK081429
510k NumberK081429
Device Name:THD SLIDE
ClassificationMonitor, Ultrasonic, Nonfetal
Applicant THD SPA 5 TIMBER LN. North Reading,  MA  01864
ContactMaureen O'connell
CorrespondentMaureen O'connell
THD SPA 5 TIMBER LN. North Reading,  MA  01864
Product CodeJAF  
CFR Regulation Number892.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-21
Decision Date2008-07-30
Summary:summary

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