The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Carbon Fiber Conformal Couch Top.
Device ID | K973842 |
510k Number | K973842 |
Device Name: | CARBON FIBER CONFORMAL COUCH TOP |
Classification | Table, Radiographic, Stationary Top |
Applicant | MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
Contact | Donald F Riibe |
Correspondent | Donald F Riibe MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-08 |
Decision Date | 1997-12-05 |