REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS

Sleeve, Limb, Compressible

ADVEN MEDICAL

The following data is part of a premarket notification filed by Adven Medical with the FDA for Reprocessed Used Disposable Sequential Compression Sleeves/wraps.

Pre-market Notification Details

Device IDK012675
510k NumberK012675
Device Name:REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
ClassificationSleeve, Limb, Compressible
Applicant ADVEN MEDICAL 1001 SLATON HWY. Lubbock,  TX  79404
ContactMark W Aldana
CorrespondentMark W Aldana
ADVEN MEDICAL 1001 SLATON HWY. Lubbock,  TX  79404
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-14
Decision Date2002-02-12
Summary:summary

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