Peripheral Blood Processing Device For Wound Management

Peripheral Blood Processing Device For Wound Management

RegenLab SA

The following data is part of a premarket notification filed by Regenlab Sa with the FDA for Peripheral Blood Processing Device For Wound Management.

Pre-market Notification Details

Device IDBK210661
510k NumberBK210661
Device Name:Peripheral Blood Processing Device For Wound Management
ClassificationPeripheral Blood Processing Device For Wound Management
Applicant RegenLab SA en Budron B2 ch-1052 Le Mont Sur Lausanne SWITZERLAND
Product CodePMQ  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-17
Decision Date2022-07-08

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.