Sequential Circulator SC-2004FC-OC

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 Sequential Circulator Sc-2004fc-oc.

Pre-market Notification Details

Device IDK171793
510k NumberK171793
Device Name:Sequential Circulator SC-2004FC-OC
ClassificationSleeve, Limb, Compressible
Applicant Bio Compression Systems, Inc. 120 W Commercial Ave Moonachie,  NJ  07074
ContactBarbara J. Whitman
CorrespondentBarbara J. Whitman
Bio Compression Systems, Inc. 120 W Commercial Ave Moonachie,  NJ  07074
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-16
Decision Date2017-08-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.