The following data is part of a premarket notification filed by Progressive Dynamics, Inc. with the FDA for Luminous 150 Dual Lampfiberoptic Illuminator.
| Device ID | K944688 |
| 510k Number | K944688 |
| Device Name: | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
| Contact | Tom Philipot |
| Correspondent | Tom Philipot PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-22 |
| Decision Date | 1994-11-01 |