← Product Code [FOK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOK) · K840894

# PHOTO-THERAPY EYE PROTECTOR (K840894)

_A & A Medical Supplies Co. · FOK · Mar 23, 1984 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOK/K840894

## Device Facts

- **Applicant:** A & A Medical Supplies Co.
- **Product Code:** [FOK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOK.md)
- **Decision Date:** Mar 23, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5270
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOK/K840894](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOK/K840894)

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