The following data is part of a premarket notification filed by Garrels X-ray Products, Inc. with the FDA for Fcw Tube Stand.
| Device ID | K862827 |
| 510k Number | K862827 |
| Device Name: | FCW TUBE STAND |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | GARRELS X-RAY PRODUCTS, INC. 3016 CENTRAL AVE. P.O. BOX 284 Ceres, CA 95307 |
| Contact | Donald Garrels |
| Correspondent | Donald Garrels GARRELS X-RAY PRODUCTS, INC. 3016 CENTRAL AVE. P.O. BOX 284 Ceres, CA 95307 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-25 |
| Decision Date | 1986-08-01 |