← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K873591

# A.R.M. (ASPEN RETURN MONITOR) (K873591)

_Qmed, Inc. · GEI · Sep 30, 1987 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K873591

## Device Facts

- **Applicant:** Qmed, Inc.
- **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md)
- **Decision Date:** Sep 30, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K873591](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K873591)

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