← Product Code [LGH](/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH) · K893380

# QCR SYSTEM I AND QCR SYSTEM II (K893380)

_Bremer Mfg. & Tool Co., Inc. · LGH · Nov 16, 1989 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K893380

## Device Facts

- **Applicant:** Bremer Mfg. & Tool Co., Inc.
- **Product Code:** [LGH](/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH.md)
- **Decision Date:** Nov 16, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.5960
- **Device Class:** Class 1
- **Review Panel:** Orthopedic

## Regulatory Identification

A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K893380](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/LGH/K893380)

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