The following data is part of a premarket notification filed by Fairmont Medical with the FDA for Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (various):x-ray Covr.
| Device ID | K972130 |
| 510k Number | K972130 |
| Device Name: | DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR |
| Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
| Applicant | FAIRMONT MEDICAL 4/21 MALVERN ST. Bayswater, Victoria, AU 3153 |
| Contact | Joann Mcbain |
| Correspondent | Joann Mcbain FAIRMONT MEDICAL 4/21 MALVERN ST. Bayswater, Victoria, AU 3153 |
| Product Code | IZJ |
| CFR Regulation Number | 892.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-06 |
| Decision Date | 1997-10-09 |
| Summary: | summary |