510(k) K961074

LIGHTSOURCE OR ILLUMINATOR by Cuda Products Co. — Product Code FSS

K961074 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "LIGHTSOURCE OR ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on Apr 30, 1996. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Cuda Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 30, 1996
Date Received
Mar 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type