The following data is part of a premarket notification filed by Progressive Dynamics, Inc. with the FDA for Luminous 250 Fiberoptic Illuminator.
Device ID | K921866 |
510k Number | K921866 |
Device Name: | LUMINOUS 250 FIBEROPTIC ILLUMINATOR |
Classification | Illuminator, Fiberoptic, Surgical Field |
Applicant | PROGRESSIVE DYNAMICS, INC. 507 INDUSTRIAL RD. Marshall, MI 49068 -1796 |
Contact | William F Lohness |
Correspondent | William F Lohness 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 | 1992-04-20 |
Decision Date | 1992-07-08 |