Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator

Sleeve, Limb, Compressible

BIO COMPRESSION SYSTEMS, INC.

The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Model Sc-3004-dl Sequential Circulator, Model Sc-3004fc-dl Sequenstial Circulator, Model Sc-2008-dl Sequential Circulator, Model Sc-3008-dl Sequential Circulator.

Pre-market Notification Details

Device IDK142640
510k NumberK142640
Device Name:Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator
ClassificationSleeve, Limb, Compressible
Applicant BIO COMPRESSION SYSTEMS, INC. 120 WEST COMMERCIAL AVE. Moonachie,  NJ  07074
ContactBarbara Whitman
CorrespondentBarbara Whitman
BIO COMPRESSION SYSTEMS, INC. 120 WEST COMMERCIAL AVE. Moonachie,  NJ  07074
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-17
Decision Date2014-11-06
Summary:summary

NIH GUDID Devices

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