KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE

Sleeve, Limb, Compressible

TYCO HEALTHCARE/KENDALL

The following data is part of a premarket notification filed by Tyco Healthcare/kendall with the FDA for Kendall Scd Sleeves (extra Large Knee, Extra Large Thigh), Kendall Scd Lexpres Sleeves (extra Large Knee, Extra Large.

Pre-market Notification Details

Device IDK051805
510k NumberK051805
Device Name:KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
ClassificationSleeve, Limb, Compressible
Applicant TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield,  MA  02048
ContactBridget Gardner
CorrespondentBridget Gardner
TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET Mansfield,  MA  02048
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-05
Decision Date2005-10-13
Summary:summary

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