The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Model 6500 Mercury Arc Light Source.
| Device ID | K896008 |
| 510k Number | K896008 |
| Device Name: | MODEL 6500 MERCURY ARC LIGHT SOURCE |
| Classification | Endoscope, Ac-powered And Accessories |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | GCP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-13 |
| Decision Date | 1989-12-27 |