The following data is part of a premarket notification filed by Tri W-g, Inc. with the FDA for Radiographic/fluoroscopic Table Model 9004.
Device ID | K911267 |
510k Number | K911267 |
Device Name: | RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 9004 |
Classification | Table, Radiographic, Tilting |
Applicant | TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Contact | David Kesler |
Correspondent | David Kesler TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-11 |
Decision Date | 1991-04-03 |