← Product Code [BTA](/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA) · K831085

# SYNEVAC VACUUM SOURCE UNIT (K831085)

_Synemed, Inc. · BTA · Jun 8, 1983 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA/K831085

## Device Facts

- **Applicant:** Synemed, Inc.
- **Product Code:** [BTA](/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA.md)
- **Decision Date:** Jun 8, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4780
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA/K831085](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BTA/K831085)

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