The following data is part of a premarket notification filed by Xre Corp. with the FDA for Trauma Stand.
Device ID | K852952 |
510k Number | K852952 |
Device Name: | TRAUMA STAND |
Classification | Tube Mount, X-ray, Diagnostic |
Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
Contact | Donna Glencross |
Correspondent | Donna Glencross XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
Product Code | IYB |
CFR Regulation Number | 892.1770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-11 |
Decision Date | 1985-09-26 |