SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES

Sleeve, Limb, Compressible

SURETEK MEDICAL

The following data is part of a premarket notification filed by Suretek Medical with the FDA for Suretek Medical Reprocessed Compression Sleeves.

Pre-market Notification Details

Device IDK052691
510k NumberK052691
Device Name:SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
ClassificationSleeve, Limb, Compressible
Applicant SURETEK MEDICAL 44 BELLWOOD FARMS Greenville,  SC  29607
ContactMike Sammon
CorrespondentMike Sammon
SURETEK MEDICAL 44 BELLWOOD FARMS Greenville,  SC  29607
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-28
Decision Date2006-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B39030121 K052691 000
B39030101 K052691 000

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