The following data is part of a premarket notification filed by Imation Corp. with the FDA for Trimax Radiographic Cassette.
Device ID | K980722 |
510k Number | K980722 |
Device Name: | TRIMAX RADIOGRAPHIC CASSETTE |
Classification | Cassette, Radiographic Film |
Applicant | IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
Contact | Stephen G Slavens |
Correspondent | Stephen G Slavens IMATION CORP. 1 IMATION PLACE Oakdale, MN 55128 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-24 |
Decision Date | 1998-03-23 |
Summary: | summary |