The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Flexible Illuminator 10.
Device ID | K840373 |
510k Number | K840373 |
Device Name: | FLEXIBLE ILLUMINATOR 10 |
Classification | Illuminator, Non-remote |
Applicant | SUNCOAST MEDICAL MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FTF |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-27 |
Decision Date | 1984-04-24 |