FIBER HEMOFILTERS FH55-FH77 & 88
Device Facts
| Record ID | K840720 |
|---|---|
| Device Name | FIBER HEMOFILTERS FH55-FH77 & 88 |
| Applicant | Gambro, Inc. |
| Product Code | KOJ · Dental |
| Decision Date | Apr 24, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6080 |
| Device Class | Class 2 |
Regulatory Classification
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.”
