HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB

Sleeve, Limb, Compressible

HYGIA HEALTH SERVICES, INC.

The following data is part of a premarket notification filed by Hygia Health Services, Inc. with the FDA for Hygia Health Services Reprocessed Nu Tech Combo, Model Left Limb And Right Limb.

Pre-market Notification Details

Device IDK012956
510k NumberK012956
Device Name:HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
ClassificationSleeve, Limb, Compressible
Applicant HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham,  AL  35211
ContactGeoff M Fatzinger
CorrespondentGeoff M Fatzinger
HYGIA HEALTH SERVICES, INC. 2800 MILAN CT., SUITE 259 Birmingham,  AL  35211
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-04
Decision Date2002-04-11
Summary:summary

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