← Product Code [KCJ](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KCJ) · K894369

# APDYNE PHENOL APPLICATOR KIT (K894369)

_Apdyne Medical Co. · KCJ · Oct 12, 1989 · Ear, Nose, Throat · SESD_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KCJ/K894369

## Device Facts

- **Applicant:** Apdyne Medical Co.
- **Product Code:** [KCJ](/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KCJ.md)
- **Decision Date:** Oct 12, 1989
- **Decision:** SESD
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.5220
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KCJ/K894369](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94therapeutic-devices/KCJ/K894369)

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