The following data is part of a premarket notification filed by Imation Enterprises Corp. with the FDA for Imation Se-204 Laser Imager.
| Device ID | K972822 |
| 510k Number | K972822 |
| Device Name: | IMATION SE-204 LASER IMAGER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | IMATION ENTERPRISES CORP. 3M CENTER, BLDG. 235-2B-23 St. Paul, MN 55144 -1000 |
| Contact | Stephen G Slavens |
| Correspondent | Stephen G Slavens IMATION ENTERPRISES CORP. 3M CENTER, BLDG. 235-2B-23 St. Paul, MN 55144 -1000 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-30 |
| Decision Date | 1997-11-19 |
| Summary: | summary |