The following data is part of a premarket notification filed by Xre Corp. with the FDA for Trauma Table Ii.
Device ID | K874114 |
510k Number | K874114 |
Device Name: | TRAUMA TABLE II |
Classification | Table, Radiographic, Tilting |
Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
Contact | Thomas F Flynn |
Correspondent | Thomas F Flynn XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-09 |
Decision Date | 1987-11-16 |