The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m Laser Imager Xl.
Device ID | K910092 |
510k Number | K910092 |
Device Name: | 3M LASER IMAGER XL |
Classification | Camera, Multi Format, Radiological |
Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 St. Paul, MN 55144 -1000 |
Contact | Gravelle |
Correspondent | Gravelle 3M MEDICAL PRODUCTS GROUP 3M CENTER, BLDG. 275-3E-08 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 | 1991-01-09 |
Decision Date | 1991-04-08 |