The following data is part of a premarket notification filed by Tri W-g, Inc. with the FDA for 745-m (magnum).
Device ID | K922980 |
510k Number | K922980 |
Device Name: | 745-M (MAGNUM) |
Classification | Table, Physical Therapy, Multi Function |
Applicant | TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Contact | Kavid Kesler |
Correspondent | Kavid Kesler TRI W-G, INC. P.O. BOX 905 Valley City, ND 58072 |
Product Code | JFB |
CFR Regulation Number | 890.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-22 |
Decision Date | 1992-07-13 |