The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Sterile Disposable Equipment Magnet Cover.
| Device ID | K970185 |
| 510k Number | K970185 |
| Device Name: | STERILE DISPOSABLE EQUIPMENT MAGNET COVER |
| Classification | Drape, Surgical |
| Applicant | CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. Grand Blanc, MI 48439 |
| Contact | Michael Czop |
| Correspondent | Michael Czop CONTOUR FABRICATORS, INC. 4100 E. BALDWIN AVE. Grand Blanc, MI 48439 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-17 |
| Decision Date | 1997-04-10 |
| Summary: | summary |