The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Lightsource Or Illuminator.
Device ID | K961074 |
510k Number | K961074 |
Device Name: | LIGHTSOURCE OR ILLUMINATOR |
Classification | Light, Surgical, Floor Standing |
Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
Contact | Kim Reed |
Correspondent | Kim Reed CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
Product Code | FSS |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-18 |
Decision Date | 1996-04-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10885403156830 | K961074 | 000 |