Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

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 Circulators Sc-1004-dl, Sc-1008-dl, Sc-2004-dl, Sc-2008-dl, Sc-4004-dl, Sc-4008-dl.

Pre-market Notification Details

Device IDK210417
510k NumberK210417
Device Name:Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
ClassificationSleeve, Limb, Compressible
Applicant Bio Compression Systems, Inc. 120 West Commercial Ave Moonachie,  NJ  07074
ContactMarc Somelofski
CorrespondentMarc Somelofski
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 Received2021-02-11
Decision Date2021-05-14

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