The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for R.l. Medical Twin Light Source.
| Device ID | K842609 |
| 510k Number | K842609 |
| Device Name: | R.L. MEDICAL TWIN LIGHT SOURCE |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | TRIDAK DIVISION OF INDICON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-05 |
| Decision Date | 1984-08-09 |