The following data is part of a premarket notification filed by Wuestec Medical, Inc. with the FDA for Lightline-m.
| Device ID | K974240 |
| 510k Number | K974240 |
| Device Name: | LIGHTLINE-M |
| Classification | Collimator, Manual, Radiographic |
| Applicant | WUESTEC MEDICAL, INC. 421 HOLCOLMBE AVE. Mobile, AL 36606 |
| Contact | Kristi White |
| Correspondent | Kristi White WUESTEC MEDICAL, INC. 421 HOLCOLMBE AVE. Mobile, AL 36606 |
| Product Code | IZX |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1997-12-22 |