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 |