The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Mt-300 Cassette Holder.
Device ID | K941600 |
510k Number | K941600 |
Device Name: | MT-300 CASSETTE HOLDER |
Classification | Cassette, Radiographic Film |
Applicant | MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
Contact | Donald Riibe |
Correspondent | Donald Riibe MEDTEC, INC. SALEM AVE. & 8TH ST. EAST HIGHWAY 10 Orange City, IA 51041 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-01 |
Decision Date | 1994-09-16 |