RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES

Sleeve, Limb, Compressible

RENU MEDICAL, INC.

The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Reporcessed Compressible Limb Sleeves.

Pre-market Notification Details

Device IDK031559
510k NumberK031559
Device Name:RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES
ClassificationSleeve, Limb, Compressible
Applicant RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett,  WA  98204
ContactL. Bruce Pierson
CorrespondentL. Bruce Pierson
RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett,  WA  98204
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-19
Decision Date2003-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10861317020221 K031559 000
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10861317020245 K031559 000
10861317020252 K031559 000
10861317020269 K031559 000
10861317020276 K031559 000
00861317023232 K031559 000

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