The following data is part of a premarket notification filed by Bayer Corp., Agfa Div. with the FDA for Lr 5200 Laser Film Recorder.
| Device ID | K964414 |
| 510k Number | K964414 |
| Device Name: | LR 5200 LASER FILM RECORDER |
| Classification | Camera, Multi Format, Radiological |
| Applicant | BAYER CORP., AGFA DIV. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Contact | Michael Sullivan |
| Correspondent | Michael Sullivan BAYER CORP., AGFA DIV. 100 CHALLENGER RD. Ridgefield Park, NJ 07660 |
| Product Code | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-05 |
| Decision Date | 1997-01-27 |
| Summary: | summary |