510(k) K901035

FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE by Cuda Products Co. — Product Code FST

K901035 is an FDA 510(k) premarket notification submitted by Cuda Products Co. for the device "FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE". The FDA issued a decision of Substantially Equivalent on April 23, 1990. The device falls under product code FST (Light, Surgical, Fiberoptic), 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
April 23, 1990
Date Received
March 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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