CTD MARK I TRACTION DEVICE

Equipment, Traction, Powered

THERASYS, INC.

The following data is part of a premarket notification filed by Therasys, Inc. with the FDA for Ctd Mark I Traction Device.

Pre-market Notification Details

Device IDK991931
510k NumberK991931
Device Name:CTD MARK I TRACTION DEVICE
ClassificationEquipment, Traction, Powered
Applicant THERASYS, INC. 2295 NORTH MORAINE DR. Moraine,  OH  45439
ContactEarnie S Philpot
CorrespondentEarnie S Philpot
THERASYS, INC. 2295 NORTH MORAINE DR. Moraine,  OH  45439
Product CodeITH  
CFR Regulation Number890.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-08
Decision Date1999-08-12

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