510(k) K901035
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