510(k) K934337
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