← Product Code [KOJ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ) · K840720

# FIBER HEMOFILTERS FH55-FH77 & 88 (K840720)

_Gambro, Inc. · KOJ · Apr 24, 1984 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K840720

## Device Facts

- **Applicant:** Gambro, Inc.
- **Product Code:** [KOJ](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ.md)
- **Decision Date:** Apr 24, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6080
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

## Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K840720](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/KOJ/K840720)

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