The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Cuda Products Corp. Lightsources.
Device ID | K933369 |
510k Number | K933369 |
Device Name: | CUDA PRODUCTS CORP. LIGHTSOURCES |
Classification | Light Source, Fiberoptic, Routine |
Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
Contact | Cynthia Arcusa |
Correspondent | Cynthia Arcusa CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-09 |
Decision Date | 1994-01-03 |