510(k) K934337

CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE by Cuda Products Co. — Product Code FSW

K934337 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE". The FDA issued a decision of Substantially Equivalent on November 18, 1993. The device falls under product code FSW (Light, Surgical, Endoscopic), 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
November 18, 1993
Date Received
September 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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