The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Fiberoptic Light Source, Foi-1a.
Device ID | K896384 |
510k Number | K896384 |
Device Name: | FIBEROPTIC LIGHT SOURCE, FOI-1A |
Classification | Source, Carrier, Fiberoptic Light |
Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
Contact | Craig Rapp |
Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
Product Code | EQH |
CFR Regulation Number | 874.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-06 |
Decision Date | 1990-01-23 |