VENAFLOW SYSTEM, MODEL 30A

Sleeve, Limb, Compressible

AIRCAST, INC.

The following data is part of a premarket notification filed by Aircast, Inc. with the FDA for Venaflow System, Model 30a.

Pre-market Notification Details

Device IDK992454
510k NumberK992454
Device Name:VENAFLOW SYSTEM, MODEL 30A
ClassificationSleeve, Limb, Compressible
Applicant AIRCAST, INC. 92 RIVER RD. Summit,  NJ  07902
ContactStephen Kenney
CorrespondentStephen Kenney
AIRCAST, INC. 92 RIVER RD. Summit,  NJ  07902
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-23
Decision Date2000-01-13

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