The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Medicam 900 Autoelectronic Light Source.
| Device ID | K922544 |
| 510k Number | K922544 |
| Device Name: | MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | KIRSCHNER MEDICAL CORP. 63 SOUTH ST. Hopkinton, MA 01748 |
| Contact | Patricia Carpenter |
| Correspondent | Patricia Carpenter KIRSCHNER MEDICAL CORP. 63 SOUTH ST. Hopkinton, MA 01748 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-08-07 |