The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Jed-light Fiberoptic Light Source.
| Device ID | K954184 |
| 510k Number | K954184 |
| Device Name: | JED-LIGHT FIBEROPTIC LIGHT SOURCE |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | JEDMED INSTRUMENT CO. 5416 JEDMED CT. St. Louis, MO 63129 -2221 |
| Contact | Craig R Parks |
| Correspondent | Craig R Parks JEDMED INSTRUMENT CO. 5416 JEDMED CT. St. Louis, MO 63129 -2221 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-11-13 |