← Product Code [JYK](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/JYK) · K822011

# SHEA'S EAR SPECULUM HOLDER PORT MANNS (K822011)

_Kelleher Corp. · JYK · Aug 12, 1982 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/JYK/K822011

## Device Facts

- **Applicant:** Kelleher Corp.
- **Product Code:** [JYK](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/JYK.md)
- **Decision Date:** Aug 12, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.1800
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/JYK/K822011](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/JYK/K822011)

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