← Product Code [KMJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ) · K951431

# AQUAGEL LUBRICATING JELLY (K951431)

_Depuy Healthcare · KMJ · Jul 21, 1995 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K951431

## Device Facts

- **Applicant:** Depuy Healthcare
- **Product Code:** [KMJ](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ.md)
- **Decision Date:** Jul 21, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6375
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K951431](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KMJ/K951431)

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