The following data is part of a premarket notification filed by Progressive Dynamics, Inc. with the FDA for Luminous 150 Fiberoptic Illuminator.
| Device ID | K933593 |
| 510k Number | K933593 |
| Device Name: | LUMINOUS 150 FIBEROPTIC ILLUMINATOR |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
| Contact | Tom Phlipot |
| Correspondent | Tom Phlipot PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1993-10-28 |