# AMICUS Separator System (BK090065)

_Fenwal Inc · Mar 4, 2010 · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK090065

## Device Facts

- **Applicant:** Fenwal Inc
- **Decision Date:** Mar 4, 2010
- **Decision:** SESE

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**Source:** [https://fda.innolitics.com/device/BK090065](https://fda.innolitics.com/device/BK090065)

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