The following data is part of a premarket notification filed by Garrels X-ray Products, Inc. with the FDA for Bsx Bucky-stand.
Device ID | K862828 |
510k Number | K862828 |
Device Name: | BSX BUCKY-STAND |
Classification | Holder, Radiographic Cassette, Wall-mounted |
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 | IXY |
CFR Regulation Number | 892.1880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-25 |
Decision Date | 1986-08-01 |