510(k) K933369

CUDA PRODUCTS CORP. LIGHTSOURCES by Cuda Products Co. — Product Code FCW

K933369 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "CUDA PRODUCTS CORP. LIGHTSOURCES". The FDA issued a decision of Substantially Equivalent on January 3, 1994. The device falls under product code FCW (Light Source, Fiberoptic, Routine), a Class II device regulated under 21 CFR 876.1500. Cuda Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1994
Date Received
July 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type