The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Franklin 9000 Wall Stand.
Device ID | K905789 |
510k Number | K905789 |
Device Name: | FRANKLIN 9000 WALL STAND |
Classification | Changer, Radiographic Film/cassette |
Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
Contact | Thomas Donohue |
Correspondent | Thomas Donohue MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
Product Code | KPX |
CFR Regulation Number | 892.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-27 |
Decision Date | 1991-05-20 |