The following data is part of a premarket notification filed by General Electric Co. with the FDA for Lum Vascular Procedure System #b5200a.
| Device ID | K883664 |
| 510k Number | K883664 |
| Device Name: | LUM VASCULAR PROCEDURE SYSTEM #B5200A |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Kroger, Phd |
| Correspondent | Kroger, Phd GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-26 |
| Decision Date | 1988-11-07 |